# K011024: Cyberknife System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray, Inc.
- Decided: Aug 10, 2001 after 128 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020294: Motion Tracking (2002), 0 descendants of its own

## Recalls of this device
- Dec 6, 2016 · Class II · Z-0865-2017: Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. T
- May 26, 2010 · Not classified · Z-2014-2010: The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay t

Source page: https://510kreport.com/device/K011024
Methodology: https://510kreport.com/methodology