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., DeepHealth, Inc. and Lunit, Inc..
FDA 510(k) Cleared Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer Devices (Product Code QDQ)
About Product Code QDQ - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code QDQ since 2018, with 34 receiving FDA clearance (average review time: 157 days).
Submission volume has increased in recent years - 16 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QDQ submissions have been consistent, averaging 163 days recently vs 150 days historically.
QDQ devices are reviewed by the Radiology panel. Browse all Radiology devices →