Cyberknife Robotic Radiosurgery System

• • Terminated Z-1098-2012 FDA Not yet classified ·initiated 16 Jan 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 dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.

• • Terminated Z-0382-2012 FDA Unclassified (pre-2012) ·initiated 7 Nov 2011

  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.

• • Terminated Z-0714-2011 FDA Unclassified (pre-2012) ·initiated 28 Oct 2010

  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.

510(k) Number

K091999 ↗

FDA Product Code

IYE

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

• Modification to Cyberknife Robotic Radiosurgery System

  Class II

  FDA 510(k) K091146 Active Cleared 1 May 2009

• 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

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