Medical Devices; Cardiovascular Devices; Classification of the   Coronary Vascular Physiologic Simulation Software Device. Final order.
The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
D002309:Cardiology / Q000295:instrumentation; D003198:Computer Simulation / Q000145:classification*; D003326:Coronary Circulation / Q000502:physiology*; D003331:Coronary Vessels; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D012984:Software / Q000145:classification*; D014481:United States