510(k) K123509 ยท JAK System, X-Ray, Tomography, Computed
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Mar 29, 2013 |
| Received | Nov 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123509
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.