510(k) K063324 ยท JAK System, X-Ray, Tomography, Computed
PET VCAR
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 23, 2007 |
| Received | Nov 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063324
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2013 | GE Healthcare, LLC GE Healthcare, PET VCAR.
PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.