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Theratron Elite

by Theratronics, Inc. 510(k)

Active United States

510(k) K983917

Overview

The Theratron Elite is a radiation therapy system that delivers radiation beams to patients for therapy. It comprises a source head, collimator, gantry, main frame, base, and counterweight. This device is classified as a System, Radiation Therapy, Radionuclide and is used in radiology applications.

The Theratron Elite is supplied by Theratronics, Inc. and has FDA 510(k) clearance with product code IWB. It is a Class II device and is not specified as single-use or reusable. The device has multiple registration numbers and is manufactured in Kanata, Ontario, Canada.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK983917 Date4 Dec 1998ClearedStatusActive

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

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1184-06 FDA Unclassified (pre-2012) initiated 8 Jul 2004
    • Terminated Z-1183-06 FDA Unclassified (pre-2012) initiated 8 Jul 2004

    The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.

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

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Questions

  • What is the Theratron Elite used for?

    The Theratron Elite is a radiation therapy system designed to deliver radiation beams to patients for therapeutic purposes. It is classified as a System, Radiation Therapy, Radionuclide and is used in radiology applications.

  • How is the Theratron Elite supplied?

    The Theratron Elite is supplied by Theratronics, Inc. It is not specified as single-use or reusable. The device has multiple registration numbers and is manufactured in Kanata, Ontario, Canada.

  • What is the regulatory status of the Theratron Elite?

    The Theratron Elite has FDA 510(k) clearance with product code IWB. It is classified as a Class II device and received a decision of 'Substantially Equivalent' on December 4, 1998.

  • What components make up the Theratron Elite system?

    The Theratron Elite comprises a source head, collimator, gantry, main frame, base, and counterweight. These components work together to deliver radiation beams to patients for therapy.