Tyto Insights for Eardrum Bulging Detection is an AI-enabled medical device from Tyto Care , Ltd., listed by FDA (De Novo, DEN250014) with a decision date of 2026-03-17. Review panel: Ear Nose & Throat.
| FDA submission number | DEN250014 |
|---|---|
| Pathway | De Novo |
| Company | Tyto Care , Ltd. |
| Review panel (specialty) | Ear Nose & Throat |
| FDA decision date | 2026-03-17 |
| Decision | Unknown |
| Product code | SHL |
| Classification | Ear, Nose, And Throat Image Analyzer |
| Device class | 2 |
| Regulation number | 874.4775 |
| Review time (calendar days) | 330 |
| Applicant country | IL |
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.