510(k) K132524 ยท JAK System, X-Ray, Tomography, Computed
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
| Applicant | Philips Medical Systems, Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Aug 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2014 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal DX/HX/EX model number: 881001
IntelliSpace Portal DX/HX/EX Upgrade model number: 881011
IntelliSpace Portal DX/HX/EX Demo model number: 881012
IntelliSpace Portal IX model number; Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.