# K161136: Precision Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Jun 24, 2016 after 63 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: 11 generations back to K914698 (1992). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150873: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System, Accuray Incorporated (2015) Summary page 5.
- K121934: Tomotherapy Treatment System, Accuray Incorporated (2012) Summary page 5.

## Most influential descendants
- K171086: Accuray Precision Treatment Planning System (2017), 1 descendant of its own
- K212794: Accuray Precision Treatment Planning System (2021), 0 descendants of its own

## Indications for use
The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

Source page: https://510kreport.com/device/K161136
Methodology: https://510kreport.com/methodology