510(k) K173607 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Edge Plus
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 21, 2018 |
| Received | Nov 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173607
| 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 |
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Edge Plus, Model Number 10267000 - 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 Edge Plus, Model Number 10267000
Product Usage:
Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissio Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.