510(k) K221065 ยท LLZ System, Image Processing, Radiological
MediLab
| Applicant | Sigma Scientific Services, LLC, Tamarac FL, US |
| Decision | Substantially Equivalent, Jun 10, 2022 |
| Received | Apr 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221065
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.