510(k) K133589 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM FORCE
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Apr 17, 2014 |
| Received | Nov 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133589
| 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 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission d Terminated |
JAK | None listed |
| Dec 2, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Force, System x-ray, tomography, computed Terminated |
JAK | None listed |
| Apr 22, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Force, Computed Tomography x-ray system
intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. Terminated |
JAK | None listed |
| Oct 6, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Force; computed tomography x-ray system.
Intended to generate and process cross-sectional images of patients. Terminated |
JAK | None listed |
| Mar 12, 2015 | Siemens Medical Solutions USA, Inc SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system.
Product Usage: The intended use of computed tomography is to produce cross-sectio Terminated |
JAK | None listed |
| Jan 14, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Force; 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 at Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.