# K993923: Adac PINNACLE3TM Radiation Therapy Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Apr 7, 2000 after 141 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914698 (1992). 11 ancestors in all.
79 later devices descend from it; 5 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951581: PINNACLE3 Apex, Adac Laboratories (1996). Our OCR of the scanned summary read K951518, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Pinnacle® Apex Treatment Planning System”.
- K926008: Pinnacle 3, Adac Laboratories (1994) Summary page 1.
- K974770: Acqplan, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 1.
- K982821: MMS Therpacplus B3DTUI Model Number 6.7, Multimedia Medical Systems, Inc. (1998) Summary page 2.
- K990833: Dose Calc, Model VS. 1.02, Integrity Medical Software, Inc. (1999) Summary page 2.

## Most influential descendants
- K013112: Focal Sim (2001), 47 descendants of its own
- K032724: PINNACLE3 Radiation Therapy Planning System (2003), 44 descendants of its own
- K041577: PINNACLE3 Radiation Therapy Planning System (2004), 39 descendants of its own
- K022036: Siemens Virtual Simulation (Vsim) (2002), 32 descendants of its own
- K080799: Atlas-Based Autosegmentation (2008), 29 descendants of its own

## Indications for use
Pinnacle®™ Radiation Therapy Planning Software is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle® Radiation Therapy Planning Software 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 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 software 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/K993923
Methodology: https://510kreport.com/methodology