Fujifilm Medical Systems U.S.A., Inc.

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Description

14 dispositivos en la base de datos

  • Modelo / Serial
    Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx || Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
  • Modelo / Serial
    363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) || 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 that can be 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.
  • Modelo / Serial
    3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    ASPIRE Cristalle (for FDR-3000AWS) || The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
  • Modelo / Serial
    2000AWS. Released Software Versions: V5.1, V6.0, V6.1. Not Released Software Versions: V5.0, V5.2, V7.0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) || The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
  • Modelo / Serial
    1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Aspire HD (for FDR-1000AWS) || The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
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Más información acerca de la data acá

  • Dirección del fabricante
    Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA