# K951581: PINNACLE3 Apex

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Apr 8, 1996 after 370 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 1 generation back to K894706 (1989). 3 ancestors in all.
83 later devices descend from it; 5 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926008: Pinnacle 3, Adac Laboratories (1994) Summary page 1.
- K894706: HT-Res RTP System, Adac Laboratories (1989) Summary page 1.
- K894722: Renner-Plan, W.D. Renner Consulting Co. (1990) Summary page 1.

## Most influential descendants
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System (2000), 79 descendants of its own
- 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

## Indications for use
This software device is intended to assist in foermulating radiation treatment plans for modalities including stereotactic radiosurgery, external photon beam, external electron beam, and brachytherapy radiation treatment of benign or malignant disease processes.

Source page: https://510kreport.com/device/K951581
Methodology: https://510kreport.com/methodology