EyeBOX is an AI-enabled medical device from Oculogica, Inc., listed by FDA (510(k), K191183) with a decision date of 2019-07-31. Review panel: Neurology.
| FDA submission number | K191183 |
|---|---|
| Pathway | 510(k) |
| Company | Oculogica, Inc. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2019-07-31 |
| Decision | Substantially Equivalent |
| Product code | QEA |
| Classification | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Device class | 2 |
| Regulation number | 882.1455 |
| Review time (calendar days) | 90 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Oculogica, Inc. · All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.