NaviCam ProScan
FDA 510(k) clearance DEN230027 · decided 2023-12-12
Clearance details
- K-number
- DEN230027
- Device name
- NaviCam ProScan
- Applicant
- Ankon Technologies Co., Ltd.
- Decision
- Unknown
- Date received
- 2023-04-14
- Decision date
- 2023-12-12
- Days to decision
- 242 days
- Clearance type
- Direct
- Product code
- QZF
- Device class
- 2
- Regulation number
- 876.1540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wuhan, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Deep Capsule® (Deep Capsule US) (K250655) | Digestaid - Artificial Intelligence Development SA | 2026-03-12 |
Recalls involving this device
No recalls on record reference this clearance.