510(k) K032748 ยท LLZ System, Image Processing, Radiological
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
| Applicant | Vital Images, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 29, 2003 |
| Received | Sep 5, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032748
| 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 |
| Nov 1, 2012 | Vital Images, Inc. Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES):
VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2
VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.