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Fuji Computed Radiography Dual Side Reading, Both Side Reading, Fcr 5501D Dual Side Reader

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

510(k) K993861

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993861 Date10 Feb 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0055-05 FDA Unclassified (pre-2012) initiated 30 Sep 2004

    Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.

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  • Withdrawn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

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