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Theratron Equinox, Models 80 CM and 100 CM

by Mds Nordion, Inc.

510(k) K053485

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 NumberK053485 Date9 Mar 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  • Withdrawn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, 19 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 Theratron Equinox, Models 80 CM and 100 CM is a Radionuclide Radiation Therapy System designed to deliver gamma radiation for external beam radiotherapy. As a cobalt teletherapy device, it emits high-energy photons to treat malignant tumors by precisely targeting cancerous tissues while minimizing exposure to surrounding healthy tissue.

This device is intended for use in radiation oncology departments within hospitals or specialized cancer treatment centers. Supplied as a reusable medical system, it adheres to safety standards including EN 60601-1 (1995) for medical electrical equipment. The Theratron Equinox operates under FDA 510(k) clearance (K053485) as a Class II device, with source heights of 80 cm and 100 cm available to accommodate varying treatment requirements. Sterility is not applicable; the system requires proper maintenance and calibration to ensure safe and effective operation.

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