510(k) K041521 ยท JAK System, X-Ray, Tomography, Computed
VOLUME VIEWER PLUS
| Applicant | General Electric Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 22, 2004 |
| Received | Jun 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2013 | GE Healthcare, LLC GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0)
Volume Analysis (Advantage Workstation Terminated |
JAK | None listed |
| Sep 20, 2008 | GE Healthcare Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.