# K212794: Accuray Precision Treatment Planning System

- Pathway: 510(k) (Special)
- Applicant: Accuray Incorporated
- Decided: Sep 30, 2021 after 28 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: 13 generations back to K914698 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171086: Accuray Precision Treatment Planning System, Accuray Incorporated (2017) Summary page 4.

## Indications for use
The Accuray 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/K212794
Methodology: https://510kreport.com/methodology