510(k) K151765 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM Perspective
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Mar 25, 2016 |
| Received | Jun 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Perspective 16
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| Nov 22, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Perspective, Computed tomography x-ray system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.