QDQ

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Product code

QDQ

Device name

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Device class

Class 2

21 CFR

21 CFR 892.2090

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

22

Summaries archived here

20 (direct download)

510(k) clearances (all years, FDA)

39 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (22)

Last three years. Most recent: 2026-08-14.

20 summaries are archived here for direct download.