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Fuji Computed Radiography Mammography Suite

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

PMA P050014510(k) K944046

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP050014 Date10 Jul 2006ApprovedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK944046 Date11 May 1995ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0662-2018 FDA Class II initiated 4 Aug 2017 on shared PMA P050014

    FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.

    • Terminated Z-1599-2016 FDA Class II initiated 1 Apr 2016

    Reports of failure of the device's power supply.

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Trade Name
Fuji's Computed Radiography Mammography Suite (Fcrms)
Generic Name
Full field digital, system, x-ray, mammographic
PMA Number
510(k) Number
FDA Product Code
IXW
Device Class
Class II
Regulation
21 CFR Part 892.1900
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji computed radiography system, forms the Fuji Computed Radiography for Mammography (FCRM) device. FCRM with a dedicated mammographic X-ray machine generates digital mammographic images used for screening and diagnosis of breast cancer.

It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation. The device is supplied as a software component and is regulated under FDA 510(k) and PMA authorizations.

Other devices from Fujifilm Medical System U.S.A., Inc.

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

Questions

AI-generated answers, 18 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 type of device is the Fuji Computed Radiography Mammography Suite?

    The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that functions as part of a digital mammography system when combined with a specified Fuji computed radiography system and a dedicated mammographic X-ray machine.

  • What is the clinical use of the Fuji Computed Radiography Mammography Suite?

    The device generates digital mammographic images intended for screening and diagnosis of breast cancer, and is used in the same clinical applications as traditional screen-film based mammographic systems.

  • How are the images from the Fuji Computed Radiography Mammography Suite interpreted?

    The mammographic images produced by the FCRM device can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.