CDSCO risk classification
Interventional and Radiology medical device classification
Every interventional and radiology device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 46 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 250
- Class A
- 51
- Class B
- 112
- Class C
- 84
- Class D
- 3
Interventional and Radiology devices and their class
250 devices
Adapter for Pre-Filled Syringe
Interventional and Radiology
Class ANon-sterile, non-measuringIt is a non-sterile accessory intended to facilitate compatibility between prefilled contrast syringes and compatible MR contrast medium injection system.
Angiographic Needle
Interventional and Radiology
Class BAngiographic needle has a unique hub design with an ergonomic feel and a black triangle indicator to orient the bevel.
Angiographic x- ray system
Interventional and Radiology
Class CAn angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium.
Angiography contrast medium injection system, battery-powered
Interventional and Radiology
Class CA battery-powered assembly of devices intended to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities).
Angiography contrast medium injection system, line-powered, mobile/stationary
Interventional and Radiology
Class CAn assembly of devices intended to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). It may additionally synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator.
Automatic Biopsy Device
Interventional and Radiology
Class BA hand-operated surgical instrument, consisting of a handpiece and a biopsy needle, intended for the automatic extraction of a sample (biopsy) from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes, etc., while causing minimal surrounding tissue damage for tissue pathological examination/testing. This is not intended for use in bone.
Automatic-aperture- control diagnostic x-ray system collimator
Interventional and Radiology
Class BA standard, diagnostic x-ray beam-limiting and shaping device intended to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas by automatically adjusting the shutters so that the x-ray beam shape matches the size of the film cassette in the holder.
Axial length measuring ultrasound system
Interventional and Radiology
Class BAn ophthalmic device intended to measure axial length of the eye (distance along the axis of the eye between the anterior corneal surface and the anterior retinal surface) using ultrasound technology.
Basic/General-purpose diagnostic x-ray system, mobile/stationary/ portable
Interventional and Radiology
Class CAn assembly of devices that comprise an analogue general- purpose diagnostic x-ray system used in a variety of routine x-ray imaging applications using analogue or analogue-to- digital technologies. It may be used for bedside imaging and for interventional and intraoperative imaging.
Biopsy Gun Handpiece (Core Biopsy Instrument)
Interventional and Radiology
Class BA hand-operated, spring-loaded surgical instrument intended to be used with a dedicated disposable biopsy needle [not included] for the automatic extraction of samples from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors (biopsy), for further examination. This is not intended for use in bone or the central nervous system. This is a reusable device.
Bladder ultrasound imaging transducer
Interventional and Radiology
Class BAn ultrasound imaging transducer assembly specifically intended to be positioned within the bladder either manually or under endoscopic guidance that steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically.
Bladder volume ultrasound imaging system
Interventional and Radiology
Class BAn assembly of devices intended for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR).
Blood flowmeter catheter, Doppler
Interventional and Radiology
Class CA flexible tube intended to be inserted into the lumen of a blood vessel to determine blood-flow velocity by measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle).
Body-orifice ultrasound imaging transducer cover
Interventional and Radiology
Class BA sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination it has no additional functionality.
Body-orifice ultrasound imaging transducer cover, image-enhancement
Interventional and Radiology
Class BIntended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging.
Bone densitometer
Interventional and Radiology
Class CA bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues.
Bone Marrow Biopsy Needle, single-use
Interventional and Radiology
Class BA hand-held device intended for harvesting bone marrow (and/or bone) specimens for pathological examination (biopsy, blood testing, etc.). This is a single-use device.
Bone sonometer
Interventional and Radiology
Class BA bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk.
Breast Localization Wire
Interventional and Radiology
Class BA sterile, non-powered device, consisting of a puncture needle and a localization (marker) wire, intended to be placed in the breast to mark non-palpable, suspicious breast lesions, acting as a guide for surgeons to precisely locate and excise tissue under image-guidance during biopsies or breast-conserving surgeries. This is not an implantable device. This is a single-use device.
Cardiovascular MRI system, Permanent magnet
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended to visualize the cardiovascular system. The device uses a permanent magnet, and can be stationary, mobile, or portable.
Cardiovascular MRI system, resistive magnet
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended to visualize the cardiovascular system. The device uses a resistive magnet.
Cardiovascular MRI system, Superconducting magnet
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended to visualize the cardiovascular system. The device uses a superconducting magnet, and can be stationary, mobile, or portable.
Cardiovascular ultrasound imaging system
Interventional and Radiology
Class CAn assembly of devices intended for imaging procedures involving the heart and blood vessels. Software packages that support a static or real-time cardiac specific imaging applications for diagnosing anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction, may be included. This does not include intracardiac or intracoronary catheters/probes.
Cephalometric digital X- ray sensor
Interventional and Radiology
Class CA sensor for a digital X-ray image processing system combined with a diagnostic X-ray system intended for visualization and size measurement of the human head (skull) using radiation.
Chest stand
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to provide a stable and adjustable platform to position patients for accurate and high-quality chest/full body X-ray examinations.
Cine or spot fluorographic x-ray camera
Interventional and Radiology
Class CA cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x- rays with an image intensifier.
Coaxial Introducer Needle, single-use
Interventional and Radiology
Class BA non-powered, image-guided (CT, ultrasound, etc.) device intended to guide and provide precise access to a biopsy needle (not included) in target tissue. This is a single-use device.
Computed radiography digital imaging scanner
Interventional and Radiology
Class BA device/device assembly intended to be used with an analogue x-ray system (not included) to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing it is not dedicated to dental use.
Computer system for ultrasound imaging system
Interventional and Radiology
Class BA mainframe computer, a personal computer (PC) or a PC- based platform, and related hardware, software and operating system software dedicated used for controlling and monitoring performance of a diagnostic ultrasound system and related image processing, display and analytical functions.
Contrast medium conservation system (Contrast management system)
Interventional and Radiology
Class BAn assembly of electromechanical devices intended to control and optimize the amount of injectible contrast agent supplied to the syringe/injector portion of the contrast medium injector system, in order to prevent unnecessary waste of contrast media during and/or between patient procedures.
Contrast medium injection system administration set
Interventional and Radiology
Class BA collection of noninvasive devices intended to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It may consist of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer. This is a disposable device.
Contrast medium injection system control unit
Interventional and Radiology
Class CAn electronic device that may be a component of a contrast medium injector system and intended to initiate and terminate the operation of a contrast medium injection procedure from a remote location (e.g., the shielded operators control room).
Contrast medium injection system hand controller kit
Interventional and Radiology
Class CA collection of non-powered devices intended to interact with a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of a high pressure line, a high pressure stopcock, and a hand-held manual controller used to stop and start the contrast medium injection system instantaneously.
Contrast medium injection system syringe
Interventional and Radiology
Class BA component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure.
Coronary optical coherence tomography system
Interventional and Radiology
Class CAn assembly of optical and computer-based devices intended for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. The system may be used during interventional cardiology, radiology, or diagnostic angiography. The system does not include an intracoronary catheter/probe.
Coronary optical coherence tomography system catheter
Interventional and Radiology
Class DA sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT).
CT contrast medium injection system, stationary/mobile
Interventional and Radiology
Class CAn assembly of devices intended to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). The system may synchronize media delivery with the x-ray generator during CT scanning.
CT phantom, test object
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to establish, validate, and provide for routine and periodic verification of patient imaging CT system performance consistent with internationally recognized standard.
CT Scan Equipment
Interventional and Radiology
Class CUse of x-ray source and digitally scanned computer technology to create cross-sectional images of the body.
Dental computed radiography digital imaging scanner
Interventional and Radiology
Class BA device/device assembly dedicated to dental use and intended to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x- ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing.
Dental digital X-ray imaging sensor
Interventional and Radiology
Class BA digital dental X-ray sensor used in the oral cavity, in combination with a general- purpose dental X-ray imaging device. The sensor consists of a CCD or other components, and comprises a sensor drive circuit and a signal processing circuit.
Dental x-ray film, screen
Interventional and Radiology
Class BA screen x-ray film specifically sized and intended for use with dental x-ray systems. It is designed to be sensitive primarily to the wavelengths of light emitted from an image intensifying screen. May be used endorally/extraorally.
Diagnostic ultrasonic transducer
Interventional and Radiology
Class BA diagnostic ultrasonic transducer is intended for use in diagnostic ultrasonic medical devices for the conversion of electrical signals into acoustic signals and vice versa.
Diagnostic x-ray beam- limiting device
Interventional and Radiology
Class BA diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
Diagnostic x-ray digital imaging conversion system
Interventional and Radiology
Class BAn assembly of medical devices intended to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. It may consist of: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector) and/or 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. It does not contain the controls for the direct operation of an x-ray imaging system.
Diagnostic x-ray digital imaging system workstation
Interventional and Radiology
Class BA freestanding component of an x-ray-based diagnostic digital imaging assembly intended to associate X- ray/CT/fluoroscopic images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. It does not have controls for direct operation of the imaging system.
Diagnostic x-ray high voltage generator
Interventional and Radiology
Class BA diagnostic x-ray high voltage generator is a device that is intended to supply and control the voltage and electrical energy provided to a diagnostic x-ray tube for medical purposes.
Diagnostic X-ray system positioning frame
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to be placed on the floor to position and support a patient, an x-ray tube assembly (not included), and an image receptor assembly (bucky) (not included) during a diagnostic x-ray procedure.
Diagnostic x-ray tube housing assembly
Interventional and Radiology
Class BA metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes lead shielding to shield unwanted x-ray radiation. It may or may not include collimators near the aperture it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing may also include attachment points, cooling means, high-voltage cables, supports for the tube and cable receptacles.
Diagnostic x-ray tube mount
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to support and to position the diagnostic x-ray tube housing assembly (not included) for a medical radiographic procedure.
Digital angiographic x-ray system, mobile/stationary/portable
Interventional and Radiology
Class CAn assembly of devices intended to visualize and optimize the macroscopic or quantitative evaluation of the anatomy and function of the blood and lymphatic systems in the heart, brain, or other organs.
Digital basic diagnostic x- ray system, mobile/portable/stationary
Interventional and Radiology
Class CAn assembly of devices intended for use in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. It is commonly used for bedside imaging and for interventional and intraoperative imaging.
Digital cephalometric x- ray system
Interventional and Radiology
Class CAn x-ray system intended to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patients head (skull). It may be used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton 3) assessment airway and other soft tissue structures.
Digital general-purpose fluoroscopic x-ray system, mobile/portable/stationary
Interventional and Radiology
Class CA general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is intended to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It is also intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time.
Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray (CR cassette)
Interventional and Radiology
Class BA device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient.
Digital intraoral dental x- ray system, mobile/portable/stationary /hand-held
Interventional and Radiology
Class CA diagnostic dental x-ray system intended to generate and control x-ray beams for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.
Digital mammographic x- ray system, mobile/stationary/portable
Interventional and Radiology
Class CAn assembly of devices specifically intended to image the breast for diagnostic purposes using x-rays. It may be used for breast cancer screening and in conjunction with biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance.
Digital panoramic/tomographic dental x-ray system (OPG)
Interventional and Radiology
Class CA diagnostic digital dental x-ray system intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures.
Digital uro-gynaecological fluoroscopic x-ray system
Interventional and Radiology
Class CA diagnostic x-ray system with real-time fluoroscopic capabilities specifically intended for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area.
Doppler blood-flow measurement ultrasound system
Interventional and Radiology
Class BA portable or stationary ultrasonic device that does not produce 2-dimensional or 3-dimensional images, and is intended to be used for determining various blood-flow related parameters.
Electrostatic x- ray imaging system
Interventional and Radiology
Class CAn electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x- radiation into an electrostatic image and, subsequently, into a visible image.
Emission computed tomography system
Interventional and Radiology
Class CAn emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data.
Extracorporeal ultrasound imaging transducer, hand- held (ultrasound probe)
Interventional and Radiology
Class BA hand-held noninvasive component of an ultrasound imaging assembly intended to be moved over the intact surface of a patients body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated).
Extremity MRI system, permanent magnet
Interventional and Radiology
Class BA diagnostic magnetic resonance imaging (MRI) system employing permanent magnet technology specifically intended to image only the head and neck or limbs.
Extremity MRI system, superconducting magnet
Interventional and Radiology
Class BA diagnostic magnetic resonance imaging (MRI) system employing superconducting magnet technology specifically intended to image only the head and neck or limbs.
Flat panel radiography and fluoroscopy system
Interventional and Radiology
Class CA digital image acquisition system in which X-rays passed through a human body are captured by an X-ray flat panel detector, and digital output signals are supplied to an image processing device to receive digital images.
Flexible endoscopic ultrasound imaging transducer
Interventional and Radiology
Class BA flexible, ultrasound imaging transducer assembly intended to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device.
Flexible ultrasound bronchoscope
Interventional and Radiology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy.
Flexible ultrasound colonoscope
Interventional and Radiology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy.
Flexible ultrasound duodenoscope
Interventional and Radiology
Class BAn endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy.
Flexible ultrasound gastroduodenoscope
Interventional and Radiology
Class BAn endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy.
Flexible ultrasound laparoscope
Interventional and Radiology
Class BAn endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy.
Fluorescent scanner
Interventional and Radiology
Class CA fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays.
Foetal cardiac monitor
Interventional and Radiology
Class CA mains electricity (AC-powered) device intended to detect, measure, and display foetal heart activity during the perinatal period.
Foetal Doppler system
Interventional and Radiology
Class CAn assembly consisting of a measuring and display unit and an attached probe or interchangeable probes intended to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The device aids in determining foetal viability.
Full-body MRI system, permanent magnet
Interventional and Radiology
Class CA general-purpose magnetic resonance imaging (MRI) system intended to scan any targeted area of the body for diagnostic imaging purposes. It includes a permanent magnet assembly.
Full-body MRI system, resistive magnet
Interventional and Radiology
Class CA diagnostic general-purpose magnetic resonance imaging (MRI) system intended to scan any targeted area of the body (full-body imaging) for diagnostic purposes. It includes a resistive magnet assembly.
Full-body MRI system, superconducting magnet
Interventional and Radiology
Class CA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly.
General- purpose ultrasound imaging system
Interventional and Radiology
Class BA stationary or mobile assembly of devices intended to collect, display, and analyse ultrasound images during a variety of ultrasound imaging procedures (e.g., OB/GYN, endoscopy, breast, prostate, etc). It does not include intracardiac/intracoronary/intracranial probes/catheters.
General-purpose diagnostic x-ray phantom, anthropomorphic
Interventional and Radiology
Class ANon-sterile, non-measuringA device intended to be used as a tissue- equivalnent model and mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ systems.
General-purpose diagnostic X-ray phantom, test object
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to provide for routine and periodic verification of the energy, hardness and intensity of an X-ray beam.
General-purpose fluoroscopic x-ray system, mobile/portable/ stationary
Interventional and Radiology
Class CA general-purpose, analog diagnostic fluoroscopic x-ray system intended to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities.
Grid for MRI (needle guide positioner)
Interventional and Radiology
Class AA non-powered device intended to position the puncture site etc., when biopsying under the magnetic resonance imaging (MRI) guide.
Hand-held intraoral dental x-ray system
Interventional and Radiology
Class CA hand-held, diagnostic dental x-ray system intended to generate and control x-ray beams used for general- purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures.
Hand-held ultrasound imaging system, body- surface
Interventional and Radiology
Class BA battery-powered, hand-held device/device assembly intended to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non- dedicated) it may in addition be intended to be used with a sterile cover for intraoperative imaging. It is not designed to be inserted into body orifices.
Hand-held ultrasound imaging system, rectal/vaginal
Interventional and Radiology
Class BA battery-powered, hand-held device/device assembly intended to be inserted in vaginal/rectal cavity for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non- dedicated) it may in addition be intended to be used with a sterile cover for intraoperative imaging.
Hand-held-detector nuclear medicine system
Interventional and Radiology
Class BAn assembly of diagnostic devices comprising a hand-held, non-imaging system intended primarily to detect, record, quantify and analyse various radioactive emissions (gamma, alpha, beta) of injected or ingested radiopharmaceuticals, radiation emitting devices, or other materials.
Head/extremity imaging MRI system
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended to visualize the head, neck, or limbs.
Hepatic ultrasound elastography system
Interventional and Radiology
Class BAn assembly of devices intended to measure liver stiffness/ultrasonic attenuation of tissues based on transient elastography for the evaluation/diagnosis of hepatic disease (e.g., liver fibrosis/steatosis) it may additionally be intended to measure spleen stiffness as an adjunct evaluation. It is typically used during diagnosis of chronic liver conditions such as viral hepatits, alcoholic hepatitis, and biliary disease, or for post-transplant evaluation.
Image- intensified fluoroscopic x-ray system
Interventional and Radiology
Class CAn image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification.
Imaging Catheter
Interventional and Radiology
Class CIntended for use with the various medical imaging consoles.
Indirect flat panel x-ray detector
Interventional and Radiology
Class BAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal it is not dedicated to imaging of a specific anatomy. It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.
Integrated ultrasound/electrocardiogr aph/stethoscope unit
Interventional and Radiology
Class BAn electrically-powered modular device intended for general medical examination using ultrasound, electrocardiograph (ECG) and auscultation modalities, with a user interface that enables synchronized data display and recording.
Integration Unit for Flat panel x-ray detector
Interventional and Radiology
Class ANon-sterile, non-measuringA portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components.
Intracardiac ultrasound imaging catheter, single- use
Interventional and Radiology
Class DA flexible tube with an ultrasonic imaging transducer at its distal tip intended for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart it is not intended for peripheral vascular or coronary artery insertion/imaging. It may be steerable. This is a single-use device.
Intracorporeal central nervous system ultrasound transducer/probe
Interventional and Radiology
Class DAn ultrasonic probe intended to be used temporarily in central nervous system surgery. It is designed to be placed at the surgical site to take local images during surgery.
Intracorporeal ultrasound transducer contouring attachment
Interventional and Radiology
Class BIntended to be used with a hand-held ultrasound imaging system transducer to provide means to replace the position of a needle guide.
Intraoperative ultrasound imaging transducer cover
Interventional and Radiology
Class BA sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.
Intraoral dental x-ray system, mobile/portable/ stationary
Interventional and Radiology
Class CA diagnostic dental x-ray system intended to generate, control and record the absorption pattern of x-ray beams for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures.
Intravascular optical coherence tomography catheter
Interventional and Radiology
Class CA catheter and a guide wire intended for use to observe a cross section of blood vessels using an optical fiber by light.
Intravascular ultrasound imaging catheter
Interventional and Radiology
Class CA flexible tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, intended for insertion into the vascular system (i.e., peripheral vascular system) by an operator it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer.
Invasive vascular ultrasound system
Interventional and Radiology
Class CA mains electricity (AC-powered) device assembly intended to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/ Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance).
Invasive vascular ultrasound system probe
Interventional and Radiology
Class CA hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively/intraoperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.
Limited view field X-ray computed tomography system
Interventional and Radiology
Class CA diagnostic X-ray computed tomography (CT) system equipped with a gantry intended exclusively for taking images of the area from the head to the neck or the extremities.
Magnetic field shielding material for cochlear implants
Interventional and Radiology
Class ANon-sterile, non-measuringAn accessory intended to be used on Cochlear implant recipients to prevent implant magnet dislodgement during MRI scans. The device is placed externally on the recipient's head by a healthcare professional prior to undergoing an MRI procedure.
Mammary Biopsy Needle
Interventional and Radiology
Class BThe growth sample is suctioned out through a needle or cut out using a surgical procedure.
Mammographic MRI system, Permanent magnet
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended for breast imaging. The device uses a permanent magnet, and can be stationary, mobile, or portable.
Mammographic MRI system, Resistive magnet
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended for breast imaging. The device uses a resistive magnet, and can be stationary, mobile, or portable.
Mammographic MRI system, Superconducting magnet
Interventional and Radiology
Class CA magnetic resonance (MR) diagnostic imaging device specifically intended for breast imaging. The device uses a superconducting magnet, and can be stationary, mobile, or portable.
Mammographic stereotactic biopsy system
Interventional and Radiology
Class BAn assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes.
Mammographic x-ray phantom, test object
Interventional and Radiology
Class ANon-sterile, non-measuringA device intended to be used as a quality assurance device in evaluation of various calibration and performance characteristics of dedicated digital or conventional diagnostic x-ray mammography systems or general-purpose x-ray systems adaptable for mammography applications. This is not a measuring device.
Mammographic x-ray system (portable/mobile/stationar y)
Interventional and Radiology
Class CA mammographic x-ray system is a device intended to be used to produce radiographs of the breast for diagnostic purposes. It may be used intraoperatively.
Mammographic x-ray system compression paddle
Interventional and Radiology
Class ANon-sterile, non-measuringA mechanically, electronically or software- controlled component of a mammographic x-ray system intended to flatten and stabilize the breast during mammography studies or mammography system-guided biopsy procedures.
Mammographic x-ray system stereotactic unit
Interventional and Radiology
Class BA device intended to be used with a diagnostic mammographic x-ray system (not included) to take multiple pictures of a breast from different angles in order to determine the exact position of a lesion in the breast. This device or technique may be built-in to some diagnostic x- ray systems for mammography.
Mammographic x-ray system, mobile/stationary/portable
Interventional and Radiology
Class CAn assembly of devices specifically intended to image the breast for diagnostic purposes. It may be used for breast cancer screening and in conjunction with the placement of biopsy markers and stereotactic biopsy and lesion localization equipment requiring x-ray guidance.
Manual contrast medium injection system
Interventional and Radiology
Class BAn assembly of devices intended for the manual-only injection of contrast media into the blood or lymphatic vessels of a patient for a diagnostic imaging procedure; it enables the operator to manually control the volume and rate of contrast media administered under pressure.
Class taken from Risk classification list of medical devices pertaining to Interventional Radiology, entry 96, because the register feed omits it.
Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Interventional and Radiology
Class ANon-sterile, non-measuringA standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use.
Medical image analyzer
Interventional and Radiology
Class BMedical image analyzers, including computer- assisted/aided detection (CADe) devices are intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.
Medical image storage device
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to provide electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.
Medical x-ray film, non- screen
Interventional and Radiology
Class ANon-sterile, non-measuringA non-screen x-ray film intended for use in medical imaging applications. Non-screen x-ray film is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens.
Medical x-ray film, screen
Interventional and Radiology
Class BA screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.
MR/CT roadmap (interpretive software)
Interventional and Radiology
Class CA stand alone software intended to synchronize live fluoroscopy images with previously acquired MRA/CTA datasets. This may be used as an aid in applications such as image-guided surgeries, calibrating the contrast medium doses, and needle guidance, etc.
MRI contrast medium injection system, mobile/stationary
Interventional and Radiology
Class CAn assembly of devices intended to inject contrast media through a small catheter and into the vascular system for magnetic resonance imaging (MRI) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using MRI). It may interface with the MRI system or a monitoring device to control timing of contrast injections.
MRI enhancement padding
Interventional and Radiology
Class ANon-sterile, non-measuringDielectric pads that are intended for use with magnetic resonance imaging systems to aid in body positioning and help reduce shading artifacts associated with the air/tissue interface during abdominal, pelvic, and neck imaging.
MRI Equipment
Interventional and Radiology
Class CIt is a medical imaging procedure using radio waves, magnetic fields, and magnetic field gradients to generate images of organs in the body.
MRI examination catheter holder
Interventional and Radiology
Class ANon-sterile, non-measuringThe device is intended to be used with ICP catheter kits to enable the catheters to be left in during MRI scanning.
MRI image interpretive software
Interventional and Radiology
Class CAn interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). It may utilize artificial intelligence (AI) and deep learning techniques.
Class taken from Risk classification list of medical devices pertaining to Interventional Radiology, entry 101, because the register feed omits it.
MRI phantom, test object
Interventional and Radiology
Class ANon-sterile, non-measuringIntended for used during evaluations of various calibration and performance characteristics of magnetic resonance imaging systems and associated image acquisition, display, and analysis computer programs.
MRI planner (radiotherapy planning application software)
Interventional and Radiology
Class CIt is a stand alone software product intended to enable a completely MRI-only workflow in radiotherapy planning. It achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software may also perform automated contouring of risk organs in certain anatomies.
MRI radio frequency coil
Interventional and Radiology
Class BThis radio frequency coil, as a component of a medical MRI system, is intended to act as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is intended to be used to enhance image resolution by improving signal to noise characteristics.
MRI system application software
Interventional and Radiology
Class CIt is a standalone software application that is intended to be used for viewing, post-processing and quantitative evaluation of magnetic resonance (MR) images for applications such as quantitative cardiovascular computed tomography (CT) evaluation, determination of the triglyceride fat fraction in MR images of the liver, multi slice and gradient echo image analysis, etc. It does not drive MRI systems.
MRI system chair
Interventional and Radiology
Class ANon-sterile, non-measuringA chair or stool specifically designed and intended to support and position a patient during examinations involving the use of a diagnostic magnetic resonance imaging (MRI) system. For MRI system compatibility these chairs/stools are made of ferromagnetically inactive materials.
MRI system synchronizer
Interventional and Radiology
Class BA physiological monitoring unit intended to be used as a component of a diagnostic magnetic resonance imaging (MRI) system, for synchronize image formation or data collection with a specific measurable physiological parameter, e.g., the beginning of a patients respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications.
MRI system table, powered
Interventional and Radiology
Class BA powered/programmable table with electronic and/or software controls intended to position and support a patient during magnetic resonance imaging (MRI) examinations.
MRI system workstation
Interventional and Radiology
Class BA standalone image-processing workstation that is intended to be networked with one or more magnetic resonance imaging (MRI) systems. The workstation may have any type of hardware, or any type of configuration. It is not intended to control or directly manipulate the diagnostic imaging device. It is intended to process MRI images and provide valuable information that allow decision making, evaluation or diagnosis of the patients pathologic conditions.
MRI-patient physiologic monitoring system
Interventional and Radiology
Class CA mobile assembly of devices intended for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations, etc.) of infant to adult intensive care patients during a magnetic resonance imaging (MRI) procedure.
Multi-modality diagnostic x-ray system (full body CT/fluoroscopic x-ray system)
Interventional and Radiology
Class CAn assembly of diagnostic x-ray devices intended to acquire, display and process images from any part of the body (full-body) incorporating the techniques of more than one x-ray imaging modality, typically including real-time fluoroscopy, two-dimensional (2D) radiography, and computed tomography (CT) it is not a single-modality system.
Needle guide positioning system for ultrasound- guided laser thermal therapy
Interventional and Radiology
Class BAn assembly of noninvasive devices intended for use during soft-tissue lesion treatment by ultrasound-guided laser thermal therapy, to provide software-based simulation of tissue thermal damage for assisting the manual positioning of percutaneous needles through which laser applicators (not included) are introduced.
Non-image- intensified fluoroscopic x-ray system
Interventional and Radiology
Class CA non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of X-ray radiation into a visible image.
Nonfetal ultrasonic monitor
Interventional and Radiology
Class BA nonfetal ultrasonic monitor is a device that projects a continuous high frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion.
Noninvasive vascular ultrasound probe
Interventional and Radiology
Class BA hand-operated component of a vascular ultrasound system intended to measure the flow of blood noninvasively by measuring flow in underlying vasculature from the body surface pre-/post-operatively, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging.
Noninvasive vascular ultrasound system
Interventional and Radiology
Class CAn electrically-powered device assembly intended to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.
Nuclear electrocardiogram synchronizer/Nuclear medicine system synchronizer
Interventional and Radiology
Class BA nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.
Nuclear medicine data processing system
Interventional and Radiology
Class CA data processing system specifically dedicated for nuclear medicine. The system is used for various types of filter processing, image display, clinical analysis, management of image storage, etc. The system may have a control system for directly operating a diagnostic imaging unit. This system can deliver or receive data online or offline, and has a configuration that can provide functions such as processing, manipulating, and displaying a patients images and information collected with the nuclear medicine scan.
Nuclear medicine system workstation
Interventional and Radiology
Class BA standalone imaging workstation specifically intended to create network connection with one or more nuclear imaging devices, such as gamma camera, PET device, and SPECT device. The workstation may have any type of hardware, or any type of configuration. It does not have controls for the direct manipulation of the imaging device.
Nuclear rectilinear scanner
Interventional and Radiology
Class BA nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient.
Nuclear scanning bed/table
Interventional and Radiology
Class ANon-sterile, non-measuringA nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedures. This does not have any measuring or therapeutic functions.
Nuclear sealed calibration source
Interventional and Radiology
Class ANon-sterile, non-measuringA nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.
Nuclear sealed source for absorption compensation
Interventional and Radiology
Class BA sealed radioisotope intended to be used for the correction of absorption of radiation from a diagnostic radioisotope by organs and tissues to improve quantitative capability of diagnostic imaging of the nuclear imaging system (PET or SPECT devices), thereby improving accuracy of diagnosis.
Nuclear tomography system/nuclear medicine system
Interventional and Radiology
Class CA nuclear tomography/medicine system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes.
Nuclear uptake probe
Interventional and Radiology
Class BA nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region
Nuclear whole body counter
Interventional and Radiology
Class BA nuclear whole body counter is a device intended to measure the amount of radioactive material in the entire body.
Nuclear whole body scanner
Interventional and Radiology
Class CA nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide- aperture detector whose position moves in one direction with respect to the patient.
Oesophageal ultrasound imaging transducer (oesophagal endosonography probe/transducer)
Interventional and Radiology
Class BAn ultrasound imaging transducer assembly intended to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment).
Ophthalmic ultrasound imaging transducer
Interventional and Radiology
Class BAn ultrasound imaging transducer that is a hand-held device intended to be moved over the intact surface of a patients eye during imaging applications involving the examination of the lens. This is a reusable device.
Optical coherence tomography (OCT) imaging system
Interventional and Radiology
Class CThe OCT (optical coherence tomography) diagnostic imaging system is intended for use in imaging of tissue characteristics and shapes of various sites (e.g., blood vessel, abdomen, lung) using near-infrared rays, without the need to obtain tissues surgically. This system may or may not contain a software package that supports the taking of both still and real-time images, and is used to diagnose anatomic abnormalities in tissues and to examine functional and anatomic features.
Optoacoustic/ultrasound imaging system
Interventional and Radiology
Class BAn assembly of electrically-powered devices intended for imaging and analysis of soft-tissue and soft-tissue vasculature using combined optoacoustic (photoacoustic: pulsed near-infrared) and ultrasound (US) imaging.
Orthopaedic x-ray ruler
Interventional and Radiology
Class AA device used in an orthopaedic clinical setting intended to be used to establish an accurate measurement of length or size related to a bone structure (i.e., length, thickness, or other aspects) when this is being viewed by the surgeon during fluoroscopy. It includes a series of notches and holes that clearly show up on the x-ray image demonstrating the distances of the viewed bone.
Panoramic digital X-ray sensor
Interventional and Radiology
Class BA sensor used in combination with a diagnostic digital dental X-ray imaging device that is specifically intended for panoramic imaging of teeth, jaw, and oral structures.
Panoramic/tomographic dental x-ray system (orthopantomography system) application software
Interventional and Radiology
Class CAn application or operating data program intended for use in, or together with a panoramic/tomographic dental x-ray system configuration for image analysis.
Paranasal ultrasound probe
Interventional and Radiology
Class BAn ultrasound transducer assembly intended to be inserted into and positioned in the paranasal sinuses for diagnostic imaging purposes. The device is also called an endoscopic ultrasound probe or ultrasound endoscopic transducer to be used in the paranasal sinuses. The device is typically incorporated in or used in combination with a device that requires ultrasonography guidance or ultrasonic wave generation, such as an endoscopic device or a needle biopsy device.
Patient audiovisual communication system
Interventional and Radiology
Class ANon-sterile, non-measuringIt is intended for use by trained personnel in functional, interventional and clinical MRI environments to facilitate audio communications during a scanning session.
PET Equipment
Interventional and Radiology
Class CIntended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.
PET infusion system
Interventional and Radiology
Class CAn assembly of devices intended to deliver accurate doses of Fluorine-18 (18F) Fluorodeoxyglucose (FDG) radiopharmaceuticals (not included) and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It may also be used to provide effective radiation shielding to medical personnel from 18F radiation exposure during nuclear medicine diagnostic procedures.
PET system
Interventional and Radiology
Class CAn assembly of devices comprising a diagnostic positron emission tomography (PET) imaging system intended to detect, record, quantify and analyse photon emission patterns to produce three-dimensional (3-D) tomographic digital cross-sectional physiological images of the patient.
PET system application software
Interventional and Radiology
Class BAn individual software program or group of programs, routines or algorithms that are intended to add specific image processing and/or analysis capabilities to a positron emission tomography (PET) imaging system configuration. Not intended to drive, control or operate the PET system.
PET/CT system
Interventional and Radiology
Class CA diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The PET and CT portions of the system may be used independently or in combination.
PET/MRI system
Interventional and Radiology
Class CA diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The PET and MRI portions of the system may be used independently or in combination.
Photofluorographic x-ray system
Interventional and Radiology
Class CA photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body.
Pneumoencephalographic chair
Interventional and Radiology
Class BIt is intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain).
Positron camera
Interventional and Radiology
Class BA positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body.
Positron CT-combined SPECT system (PET/SPECT system)
Interventional and Radiology
Class CA system intended to perform both SPECT examination and positron CT (PET) examination.
Radiographic (Non Vascular) Catheter
Interventional and Radiology
Class BInterventional radiologists obtain images using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery.
Radiographic film cassette/X-ray cassette
Interventional and Radiology
Class BA radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure to prevent direct exposure of radiographic film.
Radiographic film illuminator/X-ray LED view panel/ view box
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to be used to illuminate and view medical radiographs, including X-ray, CT, MRI, ultrasound, etc. It does not have additional functional uses.
Radiographic film marking system/ Radiographic film marker, noninvasive, reusable
Interventional and Radiology
Class ANon-sterile, non-measuringA radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light. It is not a ruler.
Radiographic film processor, automatic
Interventional and Radiology
Class ANon-sterile, non-measuringIt transports dental x-ray film from one solution to the next in the film developing process without any manual labour except the insertion of the film/cassette.
Radiographic film, non- screen
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to record images during diagnostic radiologic procedures.
Radiographic film/cassette changer
Interventional and Radiology
Class BA radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
Radiographic film/cassette changer programmer
Interventional and Radiology
Class BA radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.
Radiographic grid/X-ray grid/Anti-scatter grid
Interventional and Radiology
Class ANon-sterile, non-measuringA device intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.
Radiographic head holder
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to position the patients head during a radiographic procedure.
Radiographic intensifying screen
Interventional and Radiology
Class ANon-sterile, non-measuringIt is intended to be used to reduce the X-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.
Radiographic/X-ray cassette holder (wall-mounted/ceiling mounted/floor standing)
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to be used as a support to hold and position radiographic cassettes (not included) for a radiographic exposure for medical use.
Radiologic patient cradle
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.
Radiologic quality assurance instrument
Interventional and Radiology
Class AA radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
Radiologic table
Interventional and Radiology
Class ANon-sterile, non-measuringIntended for medical purposes to support a patient during radiologic procedures.
Radiological computer aided triage and notification software
Interventional and Radiology
Class CRadiological computer aided triage and notification software is an image processing software intended to aid in prioritization and triage of radiological medical images. The device uses computer aided image analysis of radiologic images for identification of suspicious lesions.
Radiological computer- assisted diagnostic software for lesions suspicious of cancer
Interventional and Radiology
Class CA radiological computer-assisted diagnostic software is an image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user.
Radionuclide dose calibrator
Interventional and Radiology
Class BA radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
Radionuclide rebreathing system
Interventional and Radiology
Class CA radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere).
Radionuclide test pattern phantom
Interventional and Radiology
Class ANon-sterile, non-measuringA radionuclide test pattern phantom is intended to serve as a test object for evaluating a performance characteristic of an imaging device.
Rectal/vaginal ultrasound imaging transducer
Interventional and Radiology
Class BAn invasive component of an ultrasound imaging assembly intended to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.
Scintillation (gamma) camera
Interventional and Radiology
Class BA scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector.
Semi-Automatic Biopsy Device
Interventional and Radiology
Class BA hand-held, spring-loaded device, consisting of a handpiece and a biopsy needle, and intended for obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Software for electrocardiograph with ultrasonic diagnostic system
Interventional and Radiology
Class BA software which is intended to process data obtained from an electrocardiograph with ultrasound diagnostic system. The resultant data are provided for diagnosis, etc. This term may involve the recording media where the software are stored.
SPECT system application software
Interventional and Radiology
Class BAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a positron emission tomography (PET) imaging system configuration. It is not an operating software or firmware.
SPECT system, annular detector array
Interventional and Radiology
Class CAn assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system intended exclusively for use in tomographic imaging applications. It detects, records, quantifies and analyses radionuclide emissions produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient.
SPECT system, rotating detector head
Interventional and Radiology
Class CAn assembly of devices comprising a diagnostic single photon emission computed tomography (SPECT) system that is a three-dimensional (3-D) tomographic imaging gamma camera-based system intended to detect, record, quantify and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient.
SPECT/CT system
Interventional and Radiology
Class CAn assembly of diagnostic devices that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The SPECT and CT portions of the system may be used independently or in combination and the images may be transferred to other systems for radiation therapy planning or additional processing.
Spot-film device
Interventional and Radiology
Class BA spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.
Surgical ultrasound imaging transducer
Interventional and Radiology
Class CA hand-held ultrasound imaging transducer assembly intended to be positioned within a surgical site for localized intraoperative imaging applications. This is a reusable device.
Thyroid-uptake nuclear medicine system
Interventional and Radiology
Class BAn assembly of diagnostic devices that comprise a non- imaging nuclear medicine system intended primarily for radioactive iodine related thyroid uptake measurement and analysis applications.
Tissue specimen x-ray tomography system
Interventional and Radiology
Class AAn assembly of devices intended to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. It is not intended for direct patient use.
Transilluminator for breast evaluation/Breast transilluminator (Diaphanoscope)
Interventional and Radiology
Class BAn electrically powered device intended to transmit low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), through the breast to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.
Transoesophageal vascular ultrasound monitor
Interventional and Radiology
Class BA mains electricity (AC-powered) device intended to be used for monitoring cardiac output and/or fluid status through connection to a dedicated probe, which is placed in the oesophagus to measure blood flow in the descending aorta. It may be used during a surgical procedure or in intensive care.
Transoesophageal vascular ultrasound probe
Interventional and Radiology
Class BA device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It is typically used during general anaesthesia or in intensive care. This is a single-use device.
Ultrasonic amplifier
Interventional and Radiology
Class BA unit intended for use to amplify signals transmitted from the probe of an ultrasound imaging system. This is used with an ultrasound system in the event the quality of original data transfer is lowered by the distance between the console and the imaging probe in the ultrasound system.
Ultrasonic coupling gel, non- sterile
Interventional and Radiology
Class ANon-sterile, non-measuringA coupling medium intended for use during ultrasound examinations for ultrasound transmissions.
Ultrasonic imaging catheter
Interventional and Radiology
Class BIntended for ultrasound examination of peripheral pathology only.
Ultrasonic pulsed doppler imaging system
Interventional and Radiology
Class BAn ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler- effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion.
Ultrasonic pulsed echo imaging system
Interventional and Radiology
Class BAn ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.
Ultrasonic safety goggle
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure.
Ultrasonic scanner calibrator/ Ultrasonic scanner calibration test block
Interventional and Radiology
Class ANon-sterile, non-measuringIt is a block of material with known properties intended to be used to calibrate ultrasonic scanning devices.
Ultrasound aspiration biopsy procedure kit
Interventional and Radiology
Class BA collection of sterile devices, that includes a biopsy needle and other supplies, intended to perform an ultrasound- guided aspiration sampling of tissue. This is a single-use device.
Ultrasound contrast medium, transuterine administration
Interventional and Radiology
Class BA substance/formulation (e.g., solution, gel, foam) intended to be administered into the female reproductive tract, via the vagina/uterus, to enhance diagnostic ultrasound images, typically for the evaluation of the uterine cavity and/or fallopian tube patency. (Invasive devices for application not included)
Ultrasound endoscope balloon, natural rubber latex
Interventional and Radiology
Class BA sterile balloon-like cap made of Hevea natural rubber latex (NRL) intended to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract.
Ultrasound endoscope balloon, synthetic polymer
Interventional and Radiology
Class BA sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) intended to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract.
Ultrasound imaging phantom, test object
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to provide a standard of reference for routine and periodic verification of ultrasound doppler imaging equipment used for the identification of disease and pathologies.
Ultrasound imaging system application software
Interventional and Radiology
Class BAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration.
Ultrasound imaging system multi-transducer connection unit
Interventional and Radiology
Class BAn electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held US transducers (not included) so the user can conveniently switch between transducers as required.
Ultrasound imaging system operation software
Interventional and Radiology
Class BMainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a diagnostic ultrasound system configuration.
Ultrasound imaging system operator console
Interventional and Radiology
Class BA device that is a component of a diagnostic ultrasound imaging system intended to function as the primary control panel. It includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It contains the primary controls for the direct operation of the ultrasound system.
Ultrasound imaging system table, non-powered
Interventional and Radiology
Class ANon-sterile, non-measuringA non-powered patient table intended to support and position a patient specifically for ultrasound imaging procedures.
Ultrasound imaging system table, powered
Interventional and Radiology
Class ANon-sterile, non-measuringAn electrically-powered patient table intended to support and position a patient specifically for ultrasound imaging procedures.
Ultrasound imaging system tracking positioner, reusable (ultrasound transducer bracket)
Interventional and Radiology
Class BA metal or plastic bracket intended to be applied to a hand- held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. (transducer and sensor are not included)
Ultrasound imaging transducer positioning unit
Interventional and Radiology
Class BA unit, which is an accessory to diagnostic ultrasound system, intended to position an ultrasound system imaging transducer that is inserted into the body through an endoscope and allow monitoring of the movement after placement.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Ultrasound imaging transducer positioning unit
Interventional and Radiology
Class ANon-sterile, non-measuringAn accessory to a diagnostic ultrasound imaging unit intended to position an ultrasound system imaging transducer (not included) that is inserted into the body through an endoscope.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Ultrasound imaging transducer washer- disinfector (chemical)
Interventional and Radiology
Class BA dedicated electrically-powered unit intended to be used to wash and disinfect ultrasound imaging transducers with the use of appropriate cleaning methods and chemical disinfection. Not intended for end-point disinfection/sterilization.
Ultrasound needle guide, reusable
Interventional and Radiology
Class BA non-powered device intended to direct a sharp needle (not included) into its proper course when performing ultrasound-guided clinical and/or surgical procedure including biopsies. This is a reusable device intended to be sterilized prior to use.
Ultrasound needle guide, single-use
Interventional and Radiology
Class BA non-powered, disposable device intended to direct a sharp needle (not included) into its proper course when performing ultrasound-guided clinical and/or surgical procedure including biopsies. This is a single-use device.
Ultrasound system synchronizer
Interventional and Radiology
Class BA physiological monitoring device intended to be used as a component in a diagnostic ultrasound system, to synchronize imaging acquisition and data collection with specific measurable, physiological parameters, such as the starting point of a patients respiratory or cardiac cycle. It is used mainly to reduce artifacts and to increase the signal- to-noise ratio in real-time ultrasonic imaging and in video imaging.
Vacuum-Assisted Breast Biopsy Device
Interventional and Radiology
Class BA handheld, sterile, single-use device intended for use with a vacuum-assisted biopsy system under image guidance during breast biopsy procedures.
Vacuum-Assisted Breast Biopsy System
Interventional and Radiology
Class BIt is intended to obtain breast tissue for histological examination with partial or complete removal of the imaged/palpated abnormality. The system may consist of an operating unit, vacuum unit, trolley, drive handle, foot switch, vacuum barrel assembly, disposable breast rotary probe and other accessories.
Vascular ultrasound system control unit
Interventional and Radiology
Class BA mains electricity (AC-powered) external device intended to be used to indicate (visually and/or sonically) blood flow in a peripheral blood vessel, through connection to a dedicated probe/catheter (not included), using ultrasound/Doppler/transit time technology. It may be intended to locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) or to monitor blood flow in association with microvascular surgery.
Weight-bearing protector for flat panel x-ray detector/film cassette
Interventional and Radiology
Class ANon-sterile, non-measuringThe device is intended for use as a protector for a digital X-ray flat panel detector.
X-ray film cover
Interventional and Radiology
Class ANon-sterile, non-measuringA small envelope cover intended to hold and protect x-ray films that goes into a patients mouth momentarily when taking an x-ray and then processed.
X-ray film magnifying glass
Interventional and Radiology
Class ANon-sterile, non-measuringA convex lens intended for magnifying the details of a viewed radiograph (x-ray) and shade against strong interfering light.
X-ray film processing chemical, automatic
Interventional and Radiology
Class ANon-sterile, non-measuringA chemical, e.g., a fixer or developer, intended for automatic processing of x-ray film or other radiographic films used in, e.g., computed tomography (CT), magnetic resonance (MR), ultrasound or nuclear medicine.
X-ray film processing chemical, manual
Interventional and Radiology
Class ANon-sterile, non-measuringA chemical, e.g., a fixer or developer, intended for use in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications.
X-ray film ruler
Interventional and Radiology
Class AA device used in radiology intended to superimpose accurate measurements of length (i.e., inches or millimetres) onto an x-ray film so that these measurements remain as a permanent feature of that x-ray against the anatomical structure that has been captured.
X-Ray hanger
Interventional and Radiology
Class ANon-sterile, non-measuringIntended to position and hold the radiograph during X ray film development, eliminate streaking and maintain alignment.
X-ray image intensifier
Interventional and Radiology
Class BA device intended to convert an x-ray image into a light image, then to an electronic image and finally back to a light-based image of diminished size and increased brightness. It is primarily used in fluoroscopic, angiographic, cine-fluorographic x-ray, and digital x-ray applications as it outputs an image small enough to be coupled to cine, television or spot-film cameras.
X-Ray Lead Shielding Glass
Interventional and Radiology
Class ANon-sterile, non-measuringX-ray lead shielding glass is intended to attenuate X-ray radiation and provide radiation protection while allowing visual observation in medical diagnostic imaging areas. It is used in X-ray rooms and control rooms.
X-Ray Machine
Interventional and Radiology
Class CUse of X-rays to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.
X-ray system computer, diagnostic, general- purpose
Interventional and Radiology
Class CA dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software intended to be used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions.
X-ray system synchronizer
Interventional and Radiology
Class CA physiological monitoring unit intended to be used as a component of a diagnostic x-ray system, e.g., fluoroscopy, angiography or general-purpose, to synchronize image formation or data collection with a specific measurable physiological parameter, e.g., the beginning of a patients respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to- noise ratios in various real-time or dynamic diagnostic x-ray applications. It is sometimes referred to as a gated imaging accessory or trigger.
X-ray/CT combined cardiovascular diagnostic X-ray system
Interventional and Radiology
Class CA system combining a diagnostic X-ray computed tomography (CT) and a diagnostic cardiovascular fluoroscopy system.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Risk classification list of medical devices pertaining to Interventional Radiology, CDSCO, File No. MED-16014(12)/1/2024-eoffice, 27 November 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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