Data / Medical devices / Finland / Disior OY
Disior OY: FDA-registered device maker in Helsinki Uusimaa, Finland, 6 510(k) clearances
Disior OY is registered with the FDA (registration 3018064242) in Helsinki Uusimaa, Finland. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3018064242
- Address
- HTC Helsinki, Building Pinta, Tammasaarenkatu 3, Helsinki Uusimaa, Finland, 00180
- Owner or operator
- Disior Oy (10077636)
- Roles
- Manufacturer
- First device listed
- February 9, 2021
- Registered through
- 2027
- Brand names listed
- Bonelogic, ENOS Software Guided External Fixation System, SMART Bun-Yo-Matic CT, SMART Bun-Yo-Matic Xray, SMART PCFD, SMART28 PCFD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Software For Diagnosis/Treatment | OSN | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| February 26, 2026 | K253764 | ENOS Software Guided External Fixation System | OSN | Substantially Equivalent | Disior, Ltd. | accessdata.fda.gov |
| September 29, 2025 | K250023 | SMART PCFD | QIH | Substantially Equivalent | Disior, Ltd. | accessdata.fda.gov |
| July 2, 2024 | K240736 | SMART Bun-Yo-Matic X-Ray | QIH | Substantially Equivalent | Disior, Ltd. | accessdata.fda.gov |
| June 20, 2024 | K240642 | SMART Bun-Yo-Matic CT | QIH | Substantially Equivalent | Disior, Ltd. | accessdata.fda.gov |
| December 8, 2023 | K223757 | Bonelogic | QIH | Substantially Equivalent | Disior, Ltd. | accessdata.fda.gov |
| February 5, 2021 | K203290 | Bonelogic | LLZ | Substantially Equivalent | Disior, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of Software For Diagnosis/Treatment
Updated February 26, 2026. 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.