510(k) K091103 ยท JAK System, X-Ray, Tomography, Computed
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Jun 15, 2009 |
| Received | Apr 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091103
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.