510(k) K223071 ยท LLZ System, Image Processing, Radiological
Xenoview VDP
| Applicant | Polarean, Inc., Research Triangle Park NC, US |
| Decision | Substantially Equivalent, Dec 23, 2022 |
| Received | Sep 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223071
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.