Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (1) System, X-Ray, Stationary (KPR) (1)