510(k) K120579 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM DEFINITION EDGE
| Applicant | Siemens Medical Systems, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | Feb 27, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tran Terminated |
JAK | None listed |
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.