510(k) K121072 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM DEFINITION FLASH
| Applicant | Siemens Medical Systems, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Apr 9, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121072
| 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 |
| Nov 17, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash, Computed tomography system
Product Usage:
SOMATOM Definition AS systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transm Terminated |
JAK | None listed |
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) 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.