Data / Medical devices / Finland / MVISION AI Oy
MVISION AI Oy: FDA-registered device maker in Helsinki Uusimaa, Finland, 3 510(k) clearances
MVISION AI Oy is registered with the FDA (registration 3022745617) in Helsinki Uusimaa, Finland. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022745617
- Address
- Paciuksenkatu 29 6th floor, Helsinki Uusimaa, Finland, 00270
- Owner or operator
- MVision AI (10085142)
- Roles
- Manufacturer
- First device listed
- May 16, 2022
- Registered through
- 2026
- Brand names listed
- Contour+ (MVision AI Segmentation), Dose+, MVision AI Segmentation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 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 4, 2025 | K250064 | Dose+ (1.0) | MUJ | Substantially Equivalent | Mvision AI OY | accessdata.fda.gov |
| October 18, 2024 | K241490 | Contour+ (MVision AI Segmentation) | QKB | Substantially Equivalent | Mvision AI OY | accessdata.fda.gov |
| May 3, 2022 | K212915 | MVision AI Segmentation | QKB | Substantially Equivalent | MVision AI | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of System, Planning, Radiation Therapy Treatment
Updated September 4, 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.