# K984563: The Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Accuray, Inc.
- Decided: Jul 14, 1999 after 203 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- 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 K913174 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913174: Varian Clinac 600SR, Varian Assoc., Inc. (1991) Summary page 1.

## Most influential descendants
- K143560: CygneX I System (2015), 0 descendants of its own

## Indications for use
To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.

Source page: https://510kreport.com/device/K984563
Methodology: https://510kreport.com/methodology