xvision Spine system is an AI-enabled medical device from Augmedics, Ltd., listed by FDA (510(k), K251639) with a decision date of 2025-10-03. Review panel: Neurology.
| FDA submission number | K251639 |
|---|---|
| Pathway | 510(k) |
| Company | Augmedics, Ltd. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-10-03 |
| Decision | Substantially Equivalent |
| Product code | SBF |
| Classification | Orthopedic Augmented Reality |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 127 |
| 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.