DeviceClearance

Product code QDQ— Radiology

Saige-Dx

Classification name
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Device class
Class 2
Regulation
21 CFR 892.2090
Advisory panel
Radiology
Total cleared
39
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QDQ under 21 CFR 892.2090, via openFDA

Market context for product code QDQ

FDA has cleared 39 devices under product code QDQ between 2018 and 2026, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QDQ

Recent clearances under product code QDQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.