510(k) K110834 ยท LLZ System, Image Processing, Radiological
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 26, 2011 |
| Received | Mar 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110834
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.