510(k) K063029 ยท JAK System, X-Ray, Tomography, Computed
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Nov 2, 2006 |
| Received | Oct 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063029
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.