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Our Rotating Gamma System

by Our Scientific Intl., Inc. 510(k)

Active United States

510(k) K970647

Overview

The Our Rotating Gamma System is a radiation therapy system that uses radionuclides for the treatment of selected intracranial abnormalities. It is a Class II medical device in the radiology specialty, substantially equivalent to previously cleared devices such as the Leksell Gamma Knife and Philips SRS-200 Radiosurgery System.

The device was cleared via the traditional FDA 510(k) pathway under K970647, with a decision date of May 20, 1997. It is manufactured by Our Scientific Intl., Inc. and is intended for use in radiological treatment settings as specified in its clearance.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970647 Date20 May 1997ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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

Other devices from Our Scientific Intl., Inc.

  • Explorer 3D

    Class II

Questions

  • What is the Our Rotating Gamma System used for?

    The Our Rotating Gamma System is a radiation therapy system that uses radionuclides for the treatment of selected intracranial abnormalities, as specified in its FDA 510(k) clearance.

  • How was the Our Rotating Gamma System cleared for market?

    The device was cleared via the traditional FDA 510(k) pathway under submission K970647, with a decision date of May 20, 1997, based on substantial equivalence to previously cleared devices such as the Leksell Gamma Knife and Philips SRS-200 Radiosurgery System.

  • What regulatory classification does the Our Rotating Gamma System have?

    The Our Rotating Gamma System is classified as a Class II medical device in the radiology specialty, as indicated by its FDA 510(k) clearance and product code IWB.