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Theratron 1000

by Theratronics, Inc. 510(k)

Active United States

510(k) K894165

Overview

The Theratron 1000 is a radiation therapy system using radionuclide sources, classified as a Class II medical device under FDA regulation. It is a teletherapy unit designed for external beam radiation treatment in oncology settings.

The device received FDA 510(k) clearance (K894165) on February 1, 1990, and is manufactured by Theratronics, Inc. It is intended for use in radiology and radiation therapy departments, with regulatory classification under product code IWB and regulation number 892.5750.

AI-generated from registry data, 24 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 NumberK894165 Date1 Feb 1990ClearedStatusActive

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

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Questions

  • What is the Theratron 1000 used for?

    The Theratron 1000 is a teletherapy unit designed for external beam radiation treatment in oncology settings, using radionuclide sources to deliver therapeutic radiation to patients.

  • How was the Theratron 1000 authorized for market release?

    The Theratron 1000 received FDA 510(k) clearance under submission K894165 on February 1, 1990, based on a determination of substantial equivalence to a legally marketed predicate device.

  • What regulatory classification applies to the Theratron 1000?

    The Theratron 1000 is classified as a Class II medical device under FDA regulation, with product code IWB and regulation number 892.5750, falling under the Radiology medical specialty.