510(k) K103127 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM DEFINITION AS
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Mar 4, 2011 |
| Received | Oct 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103127
| 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 Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmi Terminated |
JAK | None listed |
| Feb 14, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027
Product Usage:
Computed tomography systems intended to generate and process Terminated |
JAK | None listed |
| Feb 3, 2014 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems.
X-ray tomography, computed, radiology. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.