510(k) K033400 ยท LLZ System, Image Processing, Radiological
SENO ADVANTAGE
| Applicant | Ge Medical Systems W-400, Waukesha WI, US |
| Decision | Substantially Equivalent, Dec 4, 2003 |
| Received | Oct 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2013 | GE Healthcare, LLC GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5.
Seno Advantage is Terminated |
LLZ | None listed |
| Oct 24, 2012 | GE Healthcare, LLC GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02
A medical image review station that allows easy selection, processing, filming and media interchange of multi-m Terminated |
LLZ | None listed |
| Oct 19, 2012 | GE Healthcare, LLC GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, 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 26, 2010 | GE Healthcare, LLC GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Terminated |
LLZ | None listed |
| Jun 2, 2010 | Ge Healthcare, Llc GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02
Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interch Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.