510(k) K133030 ยท LLZ System, Image Processing, Radiological
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
| Applicant | Invivo Corporation, Florida FL, US |
| Decision | Substantially Equivalent, Jan 22, 2014 |
| Received | Sep 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2018 | Invivo Corporation DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for othe Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.