K250318 is an FDA 510(k) clearance for the Planmed XFI. This device is classified as a X-ray, Computed Tomography, Cone-beam (Class II - Special Controls, product code SFV).
Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on September 26, 2025, 234 days after receiving the submission on February 4, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750. Cone-beam Computed Tomography Produced Cross-sectional Diagnostic X-ray Images Of Whole Body Except Dental Structures..
| 510(k) Number | K250318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2025 |
| Decision Date | September 26, 2025 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | SFV — X-ray, Computed Tomography, Cone-beam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
| Definition | Cone-beam Computed Tomography Produced Cross-sectional Diagnostic X-ray Images Of Whole Body Except Dental Structures. |