# K122137: Cyberknife Robotic Radiosurgery System Cyberknife Vsi Robotic Radiosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Oct 26, 2012 after 100 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0734-2017: Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1
- Oct 31, 2014 · Class II · Z-0218-2015: Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
- Jan 13, 2014 · Class II · Z-0828-2014: Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
- Mar 19, 2013 · Class II · Z-1126-2013: A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. T

Source page: https://510kreport.com/device/K122137
Methodology: https://510kreport.com/methodology