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Parker Quality & Compliance

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Device type

Gastrointesinal Lesion Software Detection System

Product code QNP · Class II · 21 CFR 876.1520 · Gastroenterology, Urology

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.

FDA classification database

Recent 510(k)s

Sep 12, 2026

K260133

CADDIE

Odin Medical Limited

Recent recalls

No recalls in the archive for QNP.