510(k) K143416 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Definition Flash (VA48)
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Apr 16, 2015 |
| Received | Nov 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143416
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash System, x-ray, tomography, computed
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial pla Terminated |
JAK | None listed |
| Nov 8, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash
system, x-ray, tomography, computed Terminated |
JAK | None listed |
| Nov 2, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash, Computed tomography x-ray system
The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstru Terminated |
JAK | None listed |
| Aug 23, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system Terminated |
JAK | None listed |
| Oct 5, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spi Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.