Submission Details
| 510(k) Number | K250318 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Planmed XFI
Sep 2025
Decision
234d
Days
Class 2
Risk
About This 510(k) Submission
K250318 is an FDA 510(k) clearance for the Planmed XFI, 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 review panel. Regulated under 21 CFR 892.1750.
Device Classification
| 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. |
Manufacturer
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