NaviCam ProScan is an AI-enabled medical device from Ankon Technologies co., ltd, listed by FDA (De Novo, DEN230027) with a decision date of 2023-12-12. Review panel: Gastroenterology-Urology.
| FDA submission number | DEN230027 |
|---|---|
| Pathway | De Novo |
| Company | Ankon Technologies co., ltd |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2023-12-12 |
| Decision | Unknown |
| Product code | QZF |
| Classification | Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Device class | 2 |
| Regulation number | 876.1540 |
| Review time (calendar days) | 242 |
| Applicant country | CN |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.