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Gastrointestinal Capsule Endoscopy Analysis Software Device

FDA product code QZF · 2 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1540
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-03-12 – 2026-09-25

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.

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