GI Genius is an AI-enabled medical device from Cosmo Artificial Intelligence - AI, LTD, listed by FDA (De Novo, DEN200055) with a decision date of 2021-04-09. Review panel: Gastroenterology-Urology.
| FDA submission number | DEN200055 |
|---|---|
| Pathway | De Novo |
| Company | Cosmo Artificial Intelligence - AI, LTD |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2021-04-09 |
| Decision | Unknown |
| Product code | QNP |
| Classification | Gastrointesinal Lesion Software Detection System |
| Device class | 2 |
| Regulation number | 876.1520 |
| Review time (calendar days) | 213 |
| Applicant country | IE |
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.