510(k) K002519 ยท LLZ System, Image Processing, Radiological
VITREA 2, VERSION 2.1
| Applicant | Vital Images, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 19, 2000 |
| Received | Aug 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2013 | Vital Images, Inc. Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3
The software is a medical diagnostic system that allows t Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.