QZF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1540
- Medical specialty
- Gastroenterology, Urology
- 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.
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| Record | Firm | Date |
|---|---|---|
| Deep Capsule® (Deep Capsule US) (K250655) | Digestaid - Artificial Intelligence Development SA | 2026-03-12 |
| NaviCam ProScan (DEN230027) | Ankon Technologies Co., Ltd. | 2023-12-12 |
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