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Linear Accelerator Therac 25

by Atomic Energy of Canada

510(k) K837347

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK837347 Date24 Jun 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
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.

A linear accelerator, medical, used for radiation therapy. It is a computer-controlled radiation therapy machine produced by Atomic Energy of Canada Limited (AECL).

Supplied as a reusable medical device for use in clinical radiotherapy settings. Authorized under FDA 510(k) clearance K837347, classified as Class II under regulation number 892.5050, with product code IYE and advisory committee designation Radiology (RA).

Other devices from Atomic Energy of Canada

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 LINEAR ACCELERATOR THERAC 25 used for?

    The LINEAR ACCELERATOR THERAC 25 is a medical linear accelerator used for radiation therapy in clinical radiotherapy settings. It delivers computer-controlled radiation to treat cancer and other conditions requiring targeted radiation therapy.

  • Is the LINEAR ACCELERATOR THERAC 25 a reusable or single-use device?

    The LINEAR ACCELERATOR THERAC 25 is supplied as a reusable medical device, meaning it is designed for multiple uses in clinical radiotherapy settings after appropriate cleaning, maintenance, and quality assurance procedures between patients.

  • What regulatory authorization does the LINEAR ACCELERATOR THERAC 25 have?

    The LINEAR ACCELERATOR THERAC 25 is authorized under FDA 510(k) clearance K837347, which determined it to be substantially equivalent to a legally marketed predicate device. It is classified as Class II under regulation number 892.5050 with product code IYE.