EarliPoint System is an AI-enabled medical device from EarliTec Diagnostics, listed by FDA (510(k), K243891) with a decision date of 2025-03-26. Review panel: Neurology.
| FDA submission number | K243891 |
|---|---|
| Pathway | 510(k) |
| Company | EarliTec Diagnostics |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-03-26 |
| Decision | Substantially Equivalent |
| Product code | QPF |
| Classification | Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Device class | 2 |
| Regulation number | 882.1491 |
| Review time (calendar days) | 98 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.