510(k) K213660 ยท LLZ System, Image Processing, Radiological
RadAlly
| Applicant | Imaging Wave, LLC, Forrest Hills NY, US |
| Decision | Substantially Equivalent, Mar 31, 2023 |
| Received | Nov 22, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K213660
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.