Gastrointesinal Lesion Software Detection System

What Is It?

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.

How Is QNP Classified?

Gastrointesinal Lesion Software Detection System is FDA product code QNP, Class 2, 21 CFR 876.1520.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 267 days from receipt to decision on them.