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Gastrointesinal Lesion Software Detection System

FDA product code QNP · 22 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1520
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-07-23 – 2026-09-12

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.

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