K232148
- 510(k) number
- K232148
- Device name
- X-Guide Surgical Navigation System
- Applicant
- X-Nav Technologies, LLC PA · US
- Product code
- QRY — Dental Navigation System
- Decision date
- 2024-02-21
- Date received
- 2023-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K232148.pdf
Official FDA record: K232148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.