510(k) K163289 ยท JAK System, X-Ray, Tomography, Computed
syngo. CT Single Source Dual Energy (twin beam)
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI, Malvern PA, US |
| Decision | Substantially Equivalent, Feb 9, 2017 |
| Received | Nov 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163289
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.