510(k) K043333 ยท LLZ System, Image Processing, Radiological
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
| Applicant | Vital Images, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 15, 2004 |
| Received | Dec 3, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043333
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.