QNP

Gastrointesinal Lesion Software Detection System

Product code

QNP

Device name

Gastrointesinal Lesion Software Detection System

Device class

Class 2

21 CFR

21 CFR 876.1520

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

15

Summaries archived here

13 (direct download)

510(k) clearances (all years, FDA)

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

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.

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

510(k) clearances, last 3 years (15)

Last three years. Most recent: 2026-08-07.

13 summaries are archived here for direct download.