Motion Tracking

• 2 recalls, same reason

  • Terminated Z-0908-2011 FDA Unclassified (pre-2012) ·initiated 16 Mar 2009
  • Terminated Z-0909-2011 FDA Unclassified (pre-2012) ·initiated 16 Mar 2009

  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 users or patients may result in serious injury if the boom descends unexpectedly.

510(k) Number

K020294 ↗

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

See all devices from Accuray, Inc. →

• What is the Motion Tracking device used for in radiation therapy?

  Motion Tracking is a device used for radiation therapy treatment delivery systems that enables highly adaptive planning and workflows. It provides real-time motion tracking and correction capabilities to synchronize with patient movements during treatment.

• How is the Motion Tracking device supplied and what is its regulatory status?

  The device is supplied by Accuray, Inc. and is authorized under FDA 510K clearance. It is designed for use in radiology applications and is part of a suite of adaptive radiotherapy solutions that can evolve with each patient's needs.

• What are the key specifications of the Motion Tracking device?

  Motion Tracking is a Class 2 medical device with product code IYE. It was reviewed by the Radiology Advisory Committee and received FDA 510K clearance on April 22, 2002. The device is designed to work with linear accelerators and is part of adaptive radiotherapy solutions.