# K041315: Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

- Pathway: 510(k) (Special)
- Applicant: Accuray, Inc.
- Decided: Jun 10, 2004 after 24 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
No predicates in its family tree.
87 later devices descend from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061140: Trilogy Radiotherapy Delivery System (2006), 86 descendants of its own
- K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System (2007), 78 descendants of its own
- K072916: Trilogy System with Rapidarc (2007), 77 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own

## Indications for use
The CyberKnife System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K041315
Methodology: https://510kreport.com/methodology