510(k) K161009 ยท JAK System, X-Ray, Tomography, Computed
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jul 22, 2016 |
| Received | Apr 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161009
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.