510(k) K052632 ยท LLZ System, Image Processing, Radiological
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
| Applicant | Vital Images, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 15, 2005 |
| Received | Sep 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2013 | Vital Images, Inc. Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdv 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.