DeviceClearance

Product code QNP— Gastroenterology, Urology

CADDIE

Classification name
Gastrointesinal Lesion Software Detection System
Device class
Class 2
Regulation
21 CFR 876.1520
Advisory panel
Gastroenterology, Urology
Total cleared
23
First cleared
Most recent

FDA classification definition

“A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.”

— U.S. Food and Drug Administration, device classification record for product code QNP under 21 CFR 876.1520, via openFDA

Market context for product code QNP

FDA has cleared 23 devices under product code QNP between 2021 and 2026, filed by 8 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 QNP

Recent clearances under product code QNP

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