510(k) K020483 ยท LLZ System, Image Processing, Radiological
ADVANTAGE WORKSTATION 4.1
| Applicant | GE Medical Systems, Mount Prospect IL, US |
| Decision | Substantially Equivalent, Feb 28, 2002 |
| Received | Feb 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020483
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| 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.