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 Hologic, Inc. and Siemens Healthcare GmbH.
List of Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer devices (product code QDQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →