510(k) K052839 ยท JAK System, X-Ray, Tomography, Computed
CT PERFUSION 4
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 10, 2006 |
| Received | Oct 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2009 | GE Medical Systems, LLC GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles.
Image analysis software package that allows the user to produce image data and to generate information with regard to c Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.