510(k) K143400 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Definition AS/AS+
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Apr 8, 2015 |
| Received | Nov 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143400
| 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 |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS, Computed tomography system
Product Usage:
SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transm Terminated |
JAK | None listed |
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. Terminated |
JAK | None listed |
| Apr 8, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at diff Terminated |
JAK | None listed |
| Oct 5, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS, 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 spiral Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.