510(k) K130992 ยท IYE Accelerator, Linear, Medical
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
| Applicant | Philips Medical Systems (Cleveland), Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Apr 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130992
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2016 | Philips Medical Systems DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.