# K170086: Pinnacle Radiation Therapy Planning System

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 9, 2017 after 30 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010975 (2001). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130992: PINNACLE3 Radiation Therapy Planning System, Philips Medical Systems (Cleveland), Inc. (2013) Summary page 4.

## Recalls of this device
- Aug 5, 2025 · Class II · Z-2570-2025: Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientation
- Jul 17, 2025 · Class II · Z-2239-2025: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
- Aug 30, 2022 · Class II · Z-1744-2022: When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Pre

## Indications for use
Pinnacle3® Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3® Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle³ Proton, which supports proton therapy planning. The full Pinnacle3® Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques. Pinnacle3® 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/K170086
Methodology: https://510kreport.com/methodology