2 devices · 2 companies · 2023 to 2026
Product code QZF: Gastrointestinal Capsule Endoscopy Analysis Software Device
2 devices under product code QZF, 2023 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Gastrointestinal Capsule Endoscopy Analysis Software Device. 21 CFR 876.1540, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Deep CapsuleK250655 · 510(k) | Digestaid - Artificial Intelligence Development SA | Gastroenterology-Urology | database entry | |
| NaviCam ProScanDEN230027 · De Novo | Ankon Technologies co., ltd | Gastroenterology-Urology | database entry |
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