510(k) K053148 ยท JAK System, X-Ray, Tomography, Computed
CXR16
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Feb 17, 2006 |
| Received | Nov 10, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K053148
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.