510(k) K220590 ยท LLZ System, Image Processing, Radiological
aPROMISE X
| Applicant | Exini Diagnostics AB, Lund, SE |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Mar 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220590
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.