510(k) K214062 ยท KPS System, Tomography, Computed, Emission
Radialis PET Camera
| Applicant | Radialis, Inc., Thunder Bay, CA |
| Decision | Substantially Equivalent, Feb 4, 2022 |
| Received | Dec 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214062
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.