510(k) K143401 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Definition Edge
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Apr 6, 2015 |
| Received | Nov 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2019 | Siemens Medical Solutions USA, Inc syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models:
SOMATOM Definition Edge-Model #10590000;
SOMATOM Definition AS Model #8098027;
SOMATOM Definition Flash Model Terminated |
JAK | None listed |
| Aug 23, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system Terminated |
JAK | None listed |
| Oct 5, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge; 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 spir Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.