510(k) K163528 ยท JAK System, X-Ray, Tomography, Computed
HITACHI Supria Whole-body X-ray CT System Phase 3
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Mar 3, 2017 |
| Received | Dec 16, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K163528
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.