QZFClass II

Gastrointestinal Capsule Endoscopy Analysis Software Device

21 CFR 876.1540 / Gastroenterology, Urology

QZF is the FDA product code for Gastrointestinal Capsule Endoscopy Analysis Software Device, a class II device type, regulated under 21 CFR 876.1540. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2026-03-12, and no recalls.

Classification record

Product code: QZF
Device name: Gastrointestinal Capsule Endoscopy Analysis Software Device
FDA 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.
Regulation: 21 CFR 876.1540
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code QZF

By decision year

3 clearances under product code QZF with a decision year between 2023 and 2026, 2026 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code QZF by decision year
Year	Clearances
2023	1
2026	2

Applicants with the most clearances

Product code QZF

Applicants holding the most 510(k) clearances under product code QZF
Applicant	Clearances
Ankon Technologies Co., Ltd.	1
CapsoVision, Inc.	1
Digestaid - Artificial Intelligence Development SA	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Anx Robotica Corp.

Recent clearances

Product code QZF

Recent recalls

Product code QZF

FDA records show no recalls under product code QZF.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)