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Varian Ximatron C-Series Radiotherapy Treatment St

by Varian Assoc., Inc.

510(k) K853349

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK853349 Date28 Oct 1985ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0892-2011 FDA Unclassified (pre-2012) initiated 19 Jan 2010 on shared 510(k) K853349

    There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KPQ
Device Class
Class II
Regulation
21 CFR Part 892.5840
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Ximatron C-Series Radiotherapy Treatment St is a radiation therapy simulation system. It is designed to assist in the planning and simulation of radiotherapy procedures.

This device is classified as a Class II medical device under regulation number 892.5840. It received FDA 510(k) clearance under K853349 in 1985.

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