510(k) DEN230027
- Device
- NaviCam ProScan
- Applicant
- Ankon Technologies Co., Ltd.
- 510(k) number
- DEN230027
- Product code
- QZF
- Decision
- Unknown (DENG)
- Decision date
- 2023-12-12
- Date received
- 2023-04-14
- Regulation
- 876.1540
- Classification name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Feng Wang
- Address
- B3-2, B3-3, D3-4 Biolake, #666, Hi-Tech Rd., East Lake New, Technology Development Zone Wuhan CN 430075 430075
FDA Registration Numbers#
- 3016544248
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QZF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | 2026-03-12 |