Product code QZF

Device name
Gastrointestinal Capsule Endoscopy Analysis Software Device
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.1540
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.
Source
FDA openFDA device classification dataset