QZF

Gastrointestinal Capsule Endoscopy Analysis Software Device

Product code

QZF

Device name

Gastrointestinal Capsule Endoscopy Analysis Software Device

Device class

Class 2

21 CFR

21 CFR 876.1540

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-03-12.

1 summaries are archived here for direct download.