Data / Medical devices / Canada / Radialis Inc.
Radialis Inc.: FDA-registered device maker in Thunder Bay Ontario, Canada, 1 510(k) clearance
Radialis Inc. is registered with the FDA (registration 3022742930) in Thunder Bay Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022742930
- Address
- 290 Munro Street Suite 1360, Thunder Bay Ontario, Canada, P7A 7T1
- Owner or operator
- Radialis Inc. (10085216)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 20, 2022
- Registered through
- 2026
- Brand names listed
- Radialis PET Camera, Radialis PET Imager
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | 2 | Exporter to the US, 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 4, 2022 | K214062 | Radialis PET Camera | KPS | Substantially Equivalent | Radialis, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 4, 2022. 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.