xvision Spine system is an AI-enabled medical device from Augmedics Ltd., listed by FDA (510(k), K250255) with a decision date of 2025-03-13. Review panel: Neurology.
| FDA submission number | K250255 |
|---|---|
| Pathway | 510(k) |
| Company | Augmedics Ltd. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-03-13 |
| Decision | Substantially Equivalent |
| Product code | SBF |
| Classification | Orthopedic Augmented Reality |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 44 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
More devices from Augmedics Ltd. · All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.