510(k) K121213 ยท LLZ System, Image Processing, Radiological
VITREAADVANCED
| Applicant | Vital Images, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Nov 2, 2012 |
| Received | Apr 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2013 | Vital Images, Inc. Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite.
Noninvasive post-processing application designed to e Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.