510(k) K052995 ยท LLZ System, Image Processing, Radiological
ADVANTAGE WORKSTATION 4.3.
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 8, 2005 |
| Received | Oct 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052995
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2013 | GE Healthcare, LLC AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server.
K052995: Advantage Workstation 4.3 is a review station, which allows easy selecti Terminated |
LLZ | None listed |
| Aug 13, 2012 | GE Healthcare, LLC GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Vol Terminated |
LLZ | None listed |
| Aug 12, 2011 | GE Healthcare, LLC GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188
Seno Advantage is a medical image review station that allows e Terminated |
LLZ | None listed |
| Nov 28, 2007 | GE Healthcare GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volu Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.