# K091999: Cyberknife Robotic Radiosurgery System

- Pathway: 510(k) (Special)
- Applicant: Accuray, Inc.
- Decided: Sep 18, 2009 after 78 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (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. The FDA summary names no predicate by number.

## Recalls of this device
- Jan 16, 2012 · Not classified · Z-1098-2012: An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing
- Nov 7, 2011 · Not classified · Z-0382-2012: User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
- Oct 28, 2010 · Not classified · Z-0714-2011: If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.

## Indications for use
The CyberKnife VSI TM Robotic Radiosurgery 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/K091999
Methodology: https://510kreport.com/methodology