# K130992: PINNACLE3 Radiation Therapy Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 14, 2013 after 65 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010975 (2001). 28 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102216: Xio RTP System, Computerized Medical Systems, Inc. (2010) Summary page 1.

## Most influential descendants
- K151435: MRCAT (2016), 4 descendants of its own
- K182888: MRCAT Pelvis (2019), 3 descendants of its own
- K193109: MRCAT brain (2020), 2 descendants of its own
- K211841: MRI Planner (2022), 0 descendants of its own
- K214081: MRCAT Head & Neck (2022), 0 descendants of its own

## Recalls of this device
- Jan 8, 2016 · Class II · Z-0745-2016: In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.

## Indications for use
Pinnacle’” Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle®’ Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle? Proton, which supports proton therapy planning. The full Pinnacle®” Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques. Pinnacle?®” Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. Plans generated using this system is used in the determination of the course of a patient’s radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Source page: https://510kreport.com/device/K130992
Methodology: https://510kreport.com/methodology