36 devices · 18 companies · 2018 to 2026

Product code QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

36 devices under product code QDQ, 2018 to 2026, from 18 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (34 of 36 here), the regulation, and MAUDE report counts by product code.

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. 21 CFR 892.2090, Class II. A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved 2026-10-29 from FDA public records.