510(k) K203146 ยท IWB System, Radiation Therapy, Radionuclide
Akesis Galaxy RTi
| Applicant | Akesis, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Mar 5, 2021 |
| Received | Oct 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203146
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.