510(k) K192761 ยท IZI System, X-Ray, Angiographic
Asimov-MKS Imaging System
| Applicant | Onlume, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Jan 17, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192761
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.