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Cybernife Stereotactic Radiosurgery System

by Accuray, Inc.

510(k) K051941

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051941 Date9 Aug 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUJ
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CyberKnife Stereotactic Radiosurgery System is a radiation therapy treatment planning and delivery system designed for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT). It is a robotic system that delivers non-surgical treatments with sub-millimeter accuracy to various body parts including the prostate, lung, brain, spine, and liver.

The system is manufactured by Accuray, Inc. and is a Class II medical device that received FDA 510(k) clearance with K number K051941. It is intended for use in radiology applications and is supplied with various components as indicated by the multiple registration numbers provided in the device data.

Other devices from Accuray, Inc.

See all devices from Accuray, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CyberKnife Stereotactic Radiosurgery System used for?

    The CyberKnife is a robotic radiation therapy system designed for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT), delivering non-surgical treatments with sub-millimeter accuracy to various body parts including the prostate, lung, brain, spine, and liver.

  • How is the CyberKnife system supplied?

    The system is supplied with various components as indicated by the multiple registration numbers provided in the device data. It is manufactured by Accuray, Inc. and is a Class II medical device that received FDA 510(k) clearance with K number K051941.

  • What is the regulatory status of the CyberKnife system?

    The CyberKnife Stereotactic Radiosurgery System is a Class II medical device that received FDA 510(k) clearance with K number K051941 on August 9, 2005. It is intended for use in radiology applications and is manufactured by Accuray, Inc.

  • What body parts can be treated with the CyberKnife system?

    The CyberKnife system can deliver treatments with sub-millimeter accuracy to various body parts including the prostate, lung, brain, spine, and liver. It is designed for both stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT).