510(k) K113342 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM DEFINITION FLASH
| Applicant | Siemens Medical Systems, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Dec 29, 2011 |
| Received | Nov 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.