EW10-EC02 Endoscopy Support Program is an AI-enabled medical device from FUJIFILM Corporation, listed by FDA (510(k), K230751) with a decision date of 2023-12-15. Review panel: Gastroenterology-Urology.
| FDA submission number | K230751 |
|---|---|
| Pathway | 510(k) |
| Company | FUJIFILM Corporation |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2023-12-15 |
| Decision | Substantially Equivalent |
| Product code | QNP |
| Classification | Gastrointesinal Lesion Software Detection System |
| Device class | 2 |
| Regulation number | 876.1520 |
| Review time (calendar days) | 273 |
| Applicant country | JP |
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.