# K041577: PINNACLE3 Radiation Therapy Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Jun 25, 2004 after 11 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914698 (1992). 14 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032724: PINNACLE3 Radiation Therapy Planning System, Adac Laboratories (2003) Summary page 2.

## Most influential descendants
- K080799: Atlas-Based Autosegmentation (2008), 29 descendants of its own
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864 (2010), 18 descendants of its own
- K071938: Monaco RTP System (2007), 13 descendants of its own
- K091179: Monaco RTP System, Vmat Option (2009), 12 descendants of its own
- K151380: syngo.via RT Image Suite (2015), 9 descendants of its own

## 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
- Apr 23, 2015 · Class II · Z-1643-2015: A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients 
- Jul 31, 2014 · Class II · Z-2200-2015: Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden 
- Feb 11, 2014 · Class II · Z-1312-2014: Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software versio
- Oct 5, 2012 · Class II · Z-0206-2013: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
- Nov 18, 2011 · Not classified · Z-0594-2012: Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.
- Aug 21, 2007 · Not classified · Z-1212-2007: Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction

## Indications for use
Pinnacle 3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle 3 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. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are 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/K041577
Methodology: https://510kreport.com/methodology