Device type

Gastrointestinal Capsule Endoscopy Analysis Software Device

Product code QZF · Class II · 21 CFR 876.1540 · Gastroenterology, Urology

A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system.

FDA classification database