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Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)

by Varian Medical Systems, X-Ray Products-Infimed

510(k) K161459

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 NumberK161459 Date6 Sep 2016ClearedStatusActive

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  • Withdrawn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
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is a solid state X-ray imager (flat panel/digital imager) used in radiology. It is intended to replace conventional film techniques or existing digital systems in multipurpose or dedicated applications.

The system is supplied as a reusable digital imaging system for use in clinical settings. It received FDA 510(k) clearance under K161459 on 2016-09-06 and is classified under product code MQB. It was reviewed by the Radiology advisory committee and is authorized for use in the United States.

Other devices from Varian Medical Systems, X-Ray Products-Infimed

Questions

AI-generated answers, 28 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 Nexus DRTM Digital X-ray Imaging System used for?

    It is intended to replace conventional film techniques or existing digital systems in multipurpose or dedicated radiology applications, serving as a solid-state X-ray imager for clinical imaging.

  • Is the Nexus DRTM system reusable or single-use?

    The system is supplied as a reusable digital imaging system for use in clinical settings, meaning it is designed for repeated use after proper cleaning and maintenance.

  • What regulatory clearance does the Nexus DRTM system have?

    It received FDA 510(k) clearance under K161459 on September 6, 2016, and is classified under product code MQB as a solid-state X-ray imager.

  • What components are included in the Nexus DRTM system with PaxScan 4336Wv4?

    The system includes the Nexus DRTM digital X-ray imaging platform integrated with the PaxScan 4336Wv4 flat panel detector, forming a complete solid-state imaging solution.

  • Who manufactures the Nexus DRTM Digital X-ray Imaging System?

    The system is manufactured by Varian Medical Systems, X-Ray Products-Infimed, located at 121 Metropolitan Dr., Liverpool, NY 13088, United States.