QZF · Gastrointestinal Capsule Endoscopy Analysis Software Device
Gastroenterology, Urology · 21 CFR 876.1540 · Class 2
Overview
| Product Code | QZF |
|---|---|
| Device Name | Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Regulation | 21 CFR 876.1540 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | Mar 12, 2026 | SESE |
| DEN230027 | NaviCam ProScan | Ankon Technologies Co., Ltd. | Dec 12, 2023 | DENG |
Top Applicants
- Ankon Technologies Co., Ltd. — 1 clearance
- Digestaid - Artificial Intelligence Development SA — 1 clearance
