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Wired/ Wireless Fdr D-Evo with X-Ray Detection Feature

by Fujifilm Medical System U.S.A., Inc.

510(k) K111865

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 NumberK111865 Date30 Sep 2011ClearedStatusActive

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  • Withdrawn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, 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 Wired/Wireless FDR D-Evo with X-Ray Detection Feature is a solid state X-ray imager (flat panel/digital imager) that automatically detects X-rays and creates images. It features Fujifilm's 'SmartSwitch' technology which eliminates the need for a connection between the X-ray generator and DR power supply unit.

This device is supplied by Fujifilm Medical System U.S.A., Inc. and is authorized under FDA 510K clearance with product code MQB. It is designed for use in radiology settings and is available in various models as indicated by the multiple FEI numbers and registration numbers provided.

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See all devices from Fujifilm Medical System U.S.A., Inc. →

Questions

AI-generated answers, 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.

  • What is the primary function of the Wired/Wireless FDR D-Evo with X-Ray Detection Feature?

    This device is a solid state X-ray imager that automatically detects X-rays and creates digital images. It features Fujifilm's 'SmartSwitch' technology which eliminates the need for a connection between the X-ray generator and DR power supply unit.

  • How is the Wired/Wireless FDR D-Evo supplied and what models are available?

    The device is supplied by Fujifilm Medical System U.S.A., Inc. and is available in various models as indicated by the multiple FEI numbers and registration numbers provided in the device data.

  • What is the regulatory status of this device?

    The device is authorized under FDA 510K clearance with product code MQB and is classified as a solid state X-ray imager (flat panel/digital imager) in radiology settings.

  • Can the Wired/Wireless FDR D-Evo be used in both wired and wireless configurations?

    Yes, the device is designed to operate in both wired and wireless configurations, as indicated by its name, providing flexibility in radiology settings.