510(k) K081985 ยท LLZ System, Image Processing, Radiological
AW SERVER
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 25, 2008 |
| Received | Jul 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | GE Medical Systems SCS GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System Open, Classified |
LLZ | None listed |
| Oct 8, 2025 | GE Medical Systems, SCS AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 Open, Classified |
LLZ | None listed |
| 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 |
| Apr 17, 2013 | GE Healthcare, LLC GE Healthcare, AW Server.
Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system all Terminated |
LLZ | None listed |
| Jan 11, 2012 | GE Healthcare, LLC GE Healthcare AW Server version 2.0 with release 2.0 - 4.0
A medical software system that allows multiple users to remotely access AW
applications from compatible computers on a network. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.