The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K000478 ↗

FDA Product Code

IWB

Device Class

Class II

Regulation

21 CFR Part 892.5750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• 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

• Cyberknife System

  Class II

  FDA 510(k) K011024 Active Cleared 10 Aug 2001

See all devices from Accuray, Inc. →

• What types of medical conditions is the Cyberknife System V2.1 primarily used to treat?

  The Cyberknife System V2.1 is designed for treating neurological conditions, functional disorders, and spine tumors through precise, non-invasive radiosurgery and radiotherapy. Its robotic-arm-mounted linear accelerator delivers targeted radiation with high accuracy, making it suitable for minimally invasive procedures in these areas.

• How is the Cyberknife System V2.1 classified and where is it intended for use?

  The Cyberknife System V2.1 is classified as a Class II medical device and is intended for use in radiology settings. This classification reflects its role as a specialized radiation therapy system requiring controlled clinical environments.

• Is the Cyberknife System V2.1 intended for single-use or reusable applications?

  The provided data does not specify whether the Cyberknife System V2.1 is single-use or reusable. Since it is described as a system rather than a consumable or disposable component, it is likely intended for repeated use in clinical settings, though this would require confirmation from the manufacturer.

• What regulatory pathway was followed for the Cyberknife System V2.1, and which advisory committee was involved?

  The Cyberknife System V2.1 was cleared through the FDA’s 510(k) pathway, specifically under a Special clearance type (K000478) with a decision date of April 19, 2000. The review was conducted by the Radiology (RA) Advisory Committee, reflecting its intended use in radiation therapy procedures.

• Are there any specific storage conditions or sterility requirements mentioned for the Cyberknife System V2.1?

  The provided data does not include details about sterility or specific storage conditions for the Cyberknife System V2.1. Since it is a complex medical system rather than a consumable item, storage would typically follow general medical device guidelines, but users should consult the manufacturer’s instructions for precise recommendations.