X-Guide Surgical Navigation System is an AI-enabled medical device from X-Nav Technologies, LLC, listed by FDA (510(k), K232148) with a decision date of 2024-02-21. Review panel: Dental.
| FDA submission number | K232148 |
|---|---|
| Pathway | 510(k) |
| Company | X-Nav Technologies, LLC |
| Review panel (specialty) | Dental |
| FDA decision date | 2024-02-21 |
| Decision | Substantially Equivalent |
| Product code | QRY |
| Classification | Dental Navigation System |
| Device class | 2 |
| Regulation number | 872.4120 |
| Review time (calendar days) | 217 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Dental AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.