Product code QNP

Device name

Gastrointesinal Lesion Software Detection System

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1520

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset