Data / Medical devices / Finland / Planmed Oy
Planmed Oy: FDA-registered device maker in Helsinki Uusimaa, Finland, 3 510(k) clearances
Planmed Oy is registered with the FDA (registration 8043728) in Helsinki Uusimaa, Finland. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043728
- FEI number
- 3002807903
- Address
- Sorvaajankatu 7, Helsinki Uusimaa, Finland, 00880
- Owner or operator
- Planmed Oy (10023610)
- Roles
- Manufacturer
- First device listed
- August 16, 2022
- Registered through
- 2026
- Brand names listed
- Planmed Clarity 2D, Planmed Clarity S, Planmed Verity, Planmed XFI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Computed Tomography, Cone-Beam | SFV | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 26, 2025 | K250318 | Planmed XFI | SFV | Substantially Equivalent | Planmed OY | accessdata.fda.gov |
| July 18, 2022 | K211720 | Planmed Clarity 2D, Planmed Clarify S | MUE | Substantially Equivalent | Planmed OY | accessdata.fda.gov |
| April 28, 2022 | K213278 | Planmed Verity | OAS | Substantially Equivalent | Planmed OY | accessdata.fda.gov |
Compare with other makers
- All makers of Full Field Digital, System, X-Ray, Mammographic
- All makers of System, X-Ray, Tomography, Computed
- All makers of X-Ray, Tomography, Computed, Dental
Updated September 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.