510(k) K082960 ยท JAK System, X-Ray, Tomography, Computed
GE XTREME INJECTOR OPTION
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Oct 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082960
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.