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Varian C/D-Series Clinacs (Clinac 600 C/D)

by Varian Assoc., Inc.

510(k) K926321

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK926321 Date9 Aug 1994ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2383-2012 FDA Class II initiated 14 Aug 2012

    Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.

    • Terminated Z-0692-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011

    An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.

    • Terminated Z-0777-05 FDA Unclassified (pre-2012) initiated 4 Feb 2005

    Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

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  • Withdrawn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.

The Varian C/D-Series Clinacs, including the Clinac 600 C/D, are medical linear accelerators. These devices are classified as therapeutic radiology equipment used to deliver radiation therapy.

This device is regulated as a Class 2 medical device under 21 CFR 892.5050 and received FDA 510(k) clearance under the traditional pathway. It is manufactured by Varian Assoc., Inc. and is identified by product code IYE.

Other devices from Varian Assoc., Inc.

See all devices from Varian Assoc., 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 primary function of the Varian C/D-Series Clinacs?

    These devices are medical linear accelerators designed for use in therapeutic radiology to deliver radiation therapy.

  • How is the Varian C/D-Series Clinac regulated?

    The device is regulated as a Class 2 medical device under 21 CFR 892.5050 and received FDA 510(k) clearance through the traditional pathway.

  • What is the product code for this device?

    The Varian C/D-Series Clinacs are identified by the product code IYE, which is used for medical linear accelerators in the radiology specialty.