510(k) K170221 ยท JAK System, X-Ray, Tomography, Computed
syngo.CT Cardiac Planning
| Applicant | Siemens Healthcare GmbH, Forchheim, DE |
| Decision | Substantially Equivalent, Apr 21, 2017 |
| Received | Jan 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2019 | Siemens Medical Solutions USA, Inc syngo.via syngo.CT Cardiac Planning, Model Number 10496180
Product Usage:
Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angio Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.