510(k) K140912 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM SCOPE/SOMATOM SCOPE POWER
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Sep 15, 2014 |
| Received | Apr 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Scope ( Model 10967666) Terminated |
JAK | None listed |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Scope Power (Model 10967888) Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.