510(k) K050297 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM EMOTION 16
| Applicant | Siemens Medical Solution, Inc. USA, Malvern PA, US |
| Decision | Substantially Equivalent, Mar 1, 2005 |
| Received | Feb 7, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Emotion (2003)
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Sensation 10
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Sensation 16
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Emotion Duo (2003)
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| 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 4, 2014 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems
Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Terminated |
JAK | None listed |
| Sep 21, 2008 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 16. Computed tomography X-ray system Terminated |
JAK | None listed |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM CT System Emotion 16. Computed tomography x-ray system. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.