510(k) K152036 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Oct 9, 2015 |
| Received | Jul 22, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS 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 plane Terminated |
JAK | None listed |
| Nov 15, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge 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 plan Terminated |
JAK | None listed |
| Nov 2, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS, 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 reconstructi Terminated |
JAK | None listed |
| Nov 2, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge, 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 reconstruc Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.