510(k) K121517 ยท LLZ System, Image Processing, Radiological
VERSAVUE ENTERPRISE SUITE
| Applicant | Icad, Inc., Nashua NH, US |
| Decision | Substantially Equivalent, Jul 20, 2012 |
| Received | May 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121517
| 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.