# K072504: Cyberknife Robotic Radiosurgery System

- Pathway: 510(k) (Special)
- Applicant: Accuray Incorporated
- Decided: Sep 21, 2007 after 15 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (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
- Jul 21, 2009 · Not classified · Z-0853-2011: Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
- Jun 22, 2009 · Not classified · Z-1810-2009: Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
- Mar 16, 2009 · Not classified · Z-0909-2011: The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with
- Mar 16, 2009 · Not classified · Z-0908-2011: The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with
- Nov 14, 2008 · Not classified · Z-0629-2009: System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
- May 1, 2008 · Not classified · Z-1862-2008: Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
- Apr 9, 2008 · Not classified · Z-2056-2008: Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.

## Indications for use
The CyberKnife® 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/K072504
Methodology: https://510kreport.com/methodology