Medical devices; gastroenterology-urology devices; classification of the colon capsule imaging system. Final order.
The Food and Drug Administration (FDA) is classifying the colon capsule imaging system 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 colon capsule imaging system'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.
D053705:Capsule Endoscopes / Q000145:classification*; D053704:Capsule Endoscopy / Q000145:classification*; D003111:Colonic Polyps / Q000175:diagnosis; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration