BrainSee is an AI-enabled medical device from Darmiyan, Inc., listed by FDA (De Novo, DEN220066) with a decision date of 2024-01-11. Review panel: Neurology.
| FDA submission number | DEN220066 |
|---|---|
| Pathway | De Novo |
| Company | Darmiyan, Inc. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2024-01-11 |
| Decision | Unknown |
| Product code | QWT |
| Classification | Prognostic Assessment Software Of Mild Cognitive Impairment |
| Device class | 2 |
| Regulation number | 882.1454 |
| Review time (calendar days) | 469 |
| Applicant country | US |
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.