510(k) K142955 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Nov 24, 2015 |
| Received | Oct 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142955
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2020 | Siemens Medical Solutions USA, Inc SOMATOM Force, Definition AS, Definition Edge, Definition Flash,
Drive, Confidence and Edge Plus Terminated |
JAK | None listed |
| Sep 28, 2020 | Siemens Medical Solutions USA, Inc Software versions syngo.CT VB20 or VB20_SP1 in the following systems:
SOMATOM Force (Model #10742326)
SOMATOM Definition As (Model #8098027)
SOMATOM Definition Edge (Model #10590000)
SOMATOM Definitio Terminated |
JAK | None listed |
| Oct 7, 2019 | Siemens Medical Solutions USA, Inc Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner.
SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM
Definition Edge (Model #10590000 Terminated |
JAK | None listed |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 6
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 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 Perspective
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 Scope
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 Scope Power
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 Cardiac
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 64
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 Open
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 40
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system Terminated |
JAK | None listed |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system Terminated |
JAK | None listed |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system Terminated |
JAK | None listed |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.