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 Automated Radiological Image Processing Software (QIH) (1) System, image processing, radiological (LLZ) (1) System, imaging, pulsed doppler, ultrasonic (IYN) (1) System, imaging, pulsed echo, ultrasonic (IYO) (1) Transducer, ultrasonic, diagnostic (ITX) (1)