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 Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer (QDQ) (1) Radiological Computer-Assisted Prioritization Software For Lesions (QFM) (1)