510(k) K041577 ยท LNH System, Nuclear Magnetic Resonance Imaging
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
| Applicant | Adac Laboratories, Madison WI, US |
| Decision | Substantially Equivalent, Jun 25, 2004 |
| Received | Jun 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041577
| 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 |
| Jul 22, 2015 | Philips Electronics North America Corporation Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451.
UPDATED:
Pinnacle3 Software Version 8.0h, 8.0k Terminated |
LNH | None listed |
| May 21, 2015 | Philips Medical Systems, Inc. Pinnacle3 Software Version 10.0, Model 459800200841.
Product Usage:
The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to constru Terminated |
MUJ | None listed |
| Mar 31, 2014 | Philips Medical Systems (Cleveland), Inc. Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Terminated |
MUJ | None listed |
| Nov 5, 2012 | Philips Medical Systems (Cleveland), Inc. Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI.
Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide suppor Terminated |
IYE | None listed |
| Jan 11, 2012 | Philips Medical Systems (Cleveland), Inc. Pinnacle3 Radiation Therapy Planning System, software version 9.0.
Model # Description
453560446041 Pinnacle3 version 9.0 English
453560446051 Pinnacle3 version 9.0 Simplified Chinese
453 Terminated |
IYE | None listed |
| Sep 25, 2007 | Philips Nuclear Medicine, Inc. The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.