510(k) K212321 ยท LLZ System, Image Processing, Radiological
JiveX (Model Number / Release: 5.3)
| Applicant | Visus Health IT GmbH, Bochum, DE |
| Decision | Substantially Equivalent, Sep 23, 2021 |
| Received | Jul 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212321
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.