FDA Product Code QDQ: Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

Under FDA product code QDQ, radiological computer-assisted detection and diagnosis software is cleared to support radiologist interpretation of medical images.

These AI-powered tools analyze radiological images to detect and characterize findings — including pulmonary nodules, breast lesions, and bone fractures — providing quantitative measurements, confidence scores, and visual annotations that supplement the radiologist's review.

QDQ devices are Class II medical devices, regulated under 21 CFR 892.2090 and reviewed by the FDA Radiology panel.

Leading manufacturers include Screenpoint Medical B.V., Lunit, Inc. and Therapixel.