510(k) K133424 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jan 17, 2014 |
| Received | Nov 8, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2016 | Siemens Medical Solutions USA, Inc Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th Terminated |
JAK | None listed |
| Jun 27, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken a Terminated |
JAK | None listed |
| Jun 27, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at Terminated |
JAK | None listed |
| May 22, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken Terminated |
JAK | None listed |
| May 22, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane take Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.