Notal Vision Home Optical Coherence Tomography (OCT) System is an AI-enabled medical device from Notal Vision Inc, listed by FDA (De Novo, DEN230043) with a decision date of 2024-05-15. Review panel: Ophthalmic.
| FDA submission number | DEN230043 |
|---|---|
| Pathway | De Novo |
| Company | Notal Vision Inc |
| Review panel (specialty) | Ophthalmic |
| FDA decision date | 2024-05-15 |
| Decision | Unknown |
| Product code | SAX |
| Classification | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device |
| Device class | 2 |
| Regulation number | 886.1600 |
| Review time (calendar days) | 343 |
| 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.