510(k) K143409 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Definition AS Open (VA48)
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 26, 2015 |
| Received | Nov 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS
system, x-ray, tomography, computed Terminated |
JAK | None listed |
| Aug 23, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.