FDA product code QZF: Gastrointestinal Capsule Endoscopy Analysis Software Device
QZF is the FDA product code for gastrointestinal capsule endoscopy analysis software device. It is a Class II device, regulated under 21 CFR 876.1540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QZF, 1 in the last five years. The average 510(k) review took 372 days (median 372); 372 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Device class | Class II |
| Regulation | 21 CFR 876.1540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QZF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 372 |
Compare with all 510(k) review times · Search every QZF clearance
Top QZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Digestaid - Artificial Intelligence Development SA | 1 | 2026-03-12 |
Most recent QZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250655 | Digestaid - Artificial Intelligence Development SA | Deep Capsule® (Deep Capsule US) | 2026-03-12 | 372 |
Recalls for QZF devices
openFDA lists no recalls for product code QZF.
Frequently asked questions
What is FDA product code QZF?
QZF is the FDA product code for gastrointestinal capsule endoscopy analysis software device. It is a Class II device, regulated under 21 CFR 876.1540 and reviewed by the Gastroenterology and Urology panel.
What device class is QZF?
Class II, regulation 21 CFR 876.1540. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZF?
Across 1 cleared submissions the average was 372 days from receipt to decision (median 372).
Which companies have the most QZF clearances?
Digestaid - Artificial Intelligence Development SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZF
- Run a recall and safety report across every QZF manufacturer
- Watch product code QZF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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