# K032724: PINNACLE3 Radiation Therapy Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Oct 9, 2003 after 36 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 4 generations back to K914698 (1992). 13 ancestors in all.
44 later devices descend from it; 4 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System, Adac Laboratories (2000) Summary page 1.
- K002237: P3IMRT TM, Adac Laboratories (2001) Summary page 1.

## Most influential descendants
- K041577: PINNACLE3 Radiation Therapy Planning System (2004), 39 descendants of its own
- 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

## Recalls of this device
- Mar 3, 2004 · Not classified · Z-0911-04: A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong locatio

## Indications for use
Pinnacle3 Radiation Therapy Planning System version 6.6 provides support for conformal arc treatment planning. Pinnacle3 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. 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. 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/K032724
Methodology: https://510kreport.com/methodology