Data / Medical devices / Finland / Combinostics
Combinostics: FDA-registered device maker in Tampere Pirkanmaa, Finland, 3 510(k) clearances
Combinostics is registered with the FDA (registration 3014470527) in Tampere Pirkanmaa, Finland. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014470527
- Address
- Hatanpaan Valtatie 24, Tampere Pirkanmaa, Finland, 33100
- Owner or operator
- Combinostics (10057417)
- Roles
- Manufacturer
- First device listed
- April 3, 2018
- Registered through
- 2026
- Brand names listed
- cDAT, cNeuro cMRI, cNeuro cPET
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 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 |
|---|---|---|---|---|---|---|
| July 1, 2024 | K233908 | cNeuro cDAT | LLZ | Substantially Equivalent | Combinostics OY | accessdata.fda.gov |
| September 14, 2023 | K231576 | cNeuro cPET | KPS | Substantially Equivalent | Combinostics OY | accessdata.fda.gov |
| January 8, 2018 | K171328 | cNeuro cMRI | LLZ | Substantially Equivalent | Combinostics OY | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Tomography, Computed, Emission
Updated July 1, 2024. 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.