510(k) K122471 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM DEFINITION
| Applicant | Siemens Medical Systems, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Sep 11, 2012 |
| Received | Aug 14, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. Terminated |
JAK | None listed |
| Feb 3, 2014 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems.
X-ray tomography, computed, radiology. Terminated |
JAK | None listed |
| Mar 14, 2013 | Siemens Medical Solutions USA, Inc Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B.
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.