510(k) K211655 ยท LLZ System, Image Processing, Radiological
aPROMISE
| Applicant | Exini Diagnostics AB, Lund, SE |
| Decision | Substantially Equivalent, Jul 27, 2021 |
| Received | May 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211655
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.