K250318
- 510(k) number
- K250318
- Device name
- Planmed XFI
- Applicant
- Planmed OY FI
- Product code
- SFV — X-Ray, Computed Tomography, Cone-Beam
- Decision date
- 2025-09-26
- Date received
- 2025-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250318.pdf
Official FDA record: K250318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.