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Rotating Gamma System. Gamma ART-6000

by American Radiosurgery, Inc.

510(k) K060314

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060314 Date6 Apr 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
IWB
Device Class
Class II
Regulation
21 CFR Part 892.5750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Rotating Gamma System. Gamma ART-6000 is a tele-therapy radiation treatment device intended for stereotactic irradiation of intracranial structures. It utilizes 30 Cobalt-60 sources and is designed for intracranial radiosurgery, combining concepts from Gamma Knife and LINAC technologies with patented improvements.

The device is to be used by licensed medical professionals trained in its use and safety precautions. It received FDA 510(k) clearance (K060314) and is classified as a Class II medical device under regulation number 892.5750, with product code IWB and medical specialty in Radiology.

Other devices from American Radiosurgery, Inc.

Questions

AI-generated answers, 22 Sep 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 Rotating Gamma System Gamma ART-6000 used for?

    It is intended for stereotactic irradiation of intracranial structures, combining Gamma Knife and LINAC concepts with patented improvements for precise radiosurgery in the brain.

  • How many radiation sources does the Gamma ART-6000 use and what type are they?

    The device utilizes 30 Cobalt-60 sources to generate radiation for teletherapy treatment, enabling targeted intracranial irradiation.

  • Who is authorized to operate the Rotating Gamma System Gamma ART-6000?

    Only licensed medical professionals who have been trained in its use and safety precautions are authorized to operate this device.

  • What regulatory pathway was used for the Gamma ART-6000 and what is its classification?

    It received FDA 510(k) clearance under K060314 and is classified as a Class II medical device under regulation 892.5750 with product code IWB.