510(k) K091498 ยท LLZ System, Image Processing, Radiological
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
| Applicant | Vital Images, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Jun 5, 2009 |
| Received | May 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2010 | Vital Images, Inc. Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.