CATEGORIES OF MEDICAL DEVICES FOR RISK-BASED CLASSIFICATION-- S. No. Categories of Medical Devices 1 Interventional Radiology 2 Radiotherapy 3 Oncology 4 Class A (non-sterile and non-measuring) medical devices Note: All concerned associations/stakeholders are requested to forward their comments by filling the Google form at https://docs.google.com/forms/d/1eFFEU6wVU9nxgE-B40lJfeFdaMHxO_Y1jxUiQSq2sw/edit?pli=1 within 30 days from the date of publication of this draft. Name of Category: Interventional Radiology Total No. of Devices: 186 Category: Interventional Radiology S. No. Device name Intended use Risk Classification 1 Angiographic xray system An 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. Class C 2 Angiography contrast medium injection system, battery-powered A battery-powered assembly of devices designed 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). Class C 3 Angiography contrast medium injection system, line-powered, mobile/stationary An assembly of devices designed 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 consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for angiographic studies, and may be stationary or mobile (e.g., on a wheeled pedestal). Some types can synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator. Class C 4 Automatic radiographic film processor An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. Class C 5 Automaticaperture-control diagnostic x-ray system collimator A standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas. Class B 6 Axial length measuring ultrasound system An ophthalmic device that uses ultrasound technology to measure axial length of the eye (distance along the axis of the eye between the anterior corneal surface and the anterior retinal surface). Class B S. No. Device name Intended use Risk Classification 7 Basic diagnostic x-ray system table, nonpowered A non-powered table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It is not intended for use during interventional radiology/surgery. Class B 8 Basic diagnostic x-ray system table, powered A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It is not intended for use during interventional radiology/surgery. Class B 9 Basic/Generalpurpose diagnostic x-ray system, mobile/stationary /portable An assembly of devices that comprise an analogue general-purpose mobile diagnostic x-ray system used in a variety of routine x-ray imaging applications. It is typically an x-ray film based system using analogue or analogue-to-digital techniques for image capture and display. It is commonly used for bedside imaging and for interventional and intraoperative imaging. Class C 10 Bladder ultrasound imaging transducer An ultrasound imaging transducer assembly specifically designed 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. Class B 11 Bladder volume ultrasound imaging system An assembly of portable, battery-powered devices designed for more information visit acplgroupindia.co.in