510(k) K173630 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 30, 2018 |
| Received | Nov 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173630
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 14, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Confidence, Model Number 10590100
Product Usage:
Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | None listed |
| Feb 14, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge, Model Number 10590000
Product Usage:
Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray trans Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.