Modification to Cyberknife Robotic Radiosurgery System

• • Terminated Z-0890-2011 FDA Unclassified (pre-2012) ·initiated 6 Jul 2010

  Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.

• • Terminated Z-1023-2011 FDA Unclassified (pre-2012) ·initiated 15 Jan 2010

  When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available.

• • Terminated Z-1008-2011 FDA Unclassified (pre-2012) ·initiated 29 Dec 2009

  If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.

510(k) Number

K091146 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1

  Class II

  FDA 510(k) K000478 Active Cleared 19 Apr 2000

• Cyberknife System for Sterotactic Radiosurgery/Radiotherapy

  Class II

  FDA 510(k) K032345 Active Cleared 3 Sep 2003

• Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

  Class II

  FDA 510(k) K041315 Active Cleared 10 Jun 2004

• Cyberknife Robotic Radiosurgery System

  Class II

  FDA 510(k) K062967 Active Cleared 30 Oct 2006

• The Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

  Class II

  FDA 510(k) K984563 Active Cleared 14 Jul 1999

• Cyberknife System

  Class II

  FDA 510(k) K011024 Active Cleared 10 Aug 2001

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