510(k) K072821 ยท LLZ System, Image Processing, Radiological
VITREA 4DCT
| Applicant | Vital Images, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 20, 2008 |
| Received | Oct 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072821
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2010 | Vital Images, Inc. Vital, Vitrea fX and Vitrea Enterprise Suite fX
Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1
Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3
The Vitrea 4D CT Brain Perfusion option is intende Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.