510(k) K162302 · JAK System, X-Ray, Tomography, Computed
Somatom Confidence ® RT Pro
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 16, 2016 |
| Received | Aug 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2019 | Siemens Medical Solutions USA, Inc SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmiss Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.