510(k) K250318
- Device
- Planmed XFI
- Applicant
- Planmed OY
- 510(k) number
- K250318
- Product code
- SFV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-26
- Date received
- 2025-02-04
- Regulation
- 892.1750
- Classification name
- X-Ray, Computed Tomography, Cone-Beam
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Related Records
Applicant Contact
- Contact
- Niina Vuorikallas
- Address
- Sorvaajankatu 7 Helsinki FI 00880 00880
FDA Registration Numbers
- 3009154005
- 8043728