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Gammamed 12IT High Dose Rate Remote Afterloader

by Rts Technology, Inc.

510(k) K912555

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 · Traditional NumberK912555 Date2 Aug 1991ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0486-2007 FDA Unclassified (pre-2012) initiated 11 Sep 2006

    Medical device for patient treatment does not meet electrical safety standards.

    • Terminated Z-1399-06 FDA Unclassified (pre-2012) initiated 1 May 2006

    Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.

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  • Withdrawn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
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Gammamed 12IT High Dose Rate Remote Afterloader is a remote-controlled system, applicator, and radionuclide device used in radiology. It is designed for high dose rate brachytherapy procedures, delivering radioactive sources to targeted treatment sites via applicators under remote control.

This device is supplied as a reusable system and was cleared under FDA 510(k) K912555 on August 2, 1991, as substantially equivalent to a predicate device. It is classified as a Class II medical device under regulation number 892.5700 and is manufactured by Rts Technology, Inc. in North Andover, Massachusetts.

Other devices from Rts Technology, Inc.

Questions

AI-generated answers, 21 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 Gammamed 12IT High Dose Rate Remote Afterloader used for?

    The Gammamed 12IT High Dose Rate Remote Afterloader is designed for high dose rate brachytherapy procedures, delivering radioactive sources to targeted treatment sites via applicators under remote control in radiology, as it is a remote-controlled system, applicator, and radionuclide device used in radiology.

  • Is the Gammamed 12IT High Dose Rate Remote Afterloader reusable or single-use?

    The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate reprocessing, as stated in the description that it is a reusable system cleared under FDA 510(k).

  • How is the Gammamed 12IT High Dose Rate Remote Afterloader supplied and what does it include?

    The device is supplied as a reusable system that includes the remote-controlled afterloader unit, applicators, and radionuclide delivery components, enabling high dose rate brachytherapy procedures through remote control of radioactive source placement.