510(k) K090808 ยท MUJ System, Planning, Radiation Therapy Treatment
PINNACLE3 SMARTARC
| Applicant | Philips Medical Systems, Inc., Fitchburg WI, US |
| Decision | Substantially Equivalent, Apr 3, 2009 |
| Received | Mar 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2025 | Philips Medical Systems (Cleveland) Inc Pinnacle Radiation Therapy Planning System:
Multimodality Simulation Workspace 18.0.5 Model 870258
UDI code: (01)00884838103566(10)18.0.5.22236
Pinnacle TumorLOC 16.2 Model 870226
UDI code: (01)0088 Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.