510(k) K190578 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 27, 2019 |
| Received | Mar 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Confidence -Computed tomography systems
Model 10590100 Open, Classified |
JAK | None listed |
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS-Computed tomography system
Model 8098027 Open, Classified |
JAK | None listed |
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Edge Plus-Computed tomography system
Model 1026700 Open, Classified |
JAK | None listed |
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge -Computed tomography system
Model 10590000 Open, Classified |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Force with software syngo.CT VB20
Model #10742326 Terminated |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS with software syngo.CT VB20
Model #8098027 Terminated |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge with software syngo.CT VB20
Model #10590000 Terminated |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash with software syngo.CT VB20
Model #10430603 Terminated |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Drive with software syngo.CT VB20
Model #10431700 Terminated |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Confidence with software syngo.CT VB20
Model #10590100 Terminated |
JAK | None listed |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Edge Plus with software syngo.CT VB20
Model #10267000 Terminated |
JAK | None listed |
| Jul 25, 2019 | Siemens Medical Solutions USA, Inc syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models:
SOMATOM Definition Edge-Model #10590000;
SOMATOM Definition AS Model #8098027;
SOMATOM Definition Flash Model Terminated |
JAK | None listed |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tra Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.