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510(k) Data Aggregation

    K Number
    K133972
    Device Name
    ASPIRE CRISTALLE
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS, USA INC.
    Date Cleared
    2014-03-25

    (89 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJIFILM MEDICAL SYSTEMS, USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    The ASPIRE Cristalle is an integrated FFDM system combining an X-ray system made by Fujifilm with Fujifilm's a-Se detector and Acquisition Workstation (AWS). The ASPIRE Cristalle creates digital mammography images by direct capture of x-ray energy using the a-Se detector. The detector is a Fujifilm design utilizing an a-Se photo-conversion layer with TFT Readout circuitry to acquire image data and transfer images to the AWS for automated post processing, technologist preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and three AEC modes. The ASPIRE Cristalle Acquisition Workstation (FDR 3000A WS) includes an off the shelf personal computer, the application software, Windows 7 Operating System, a 5megapixel portrait type monitor, and a hub. The hub transmits signals between the personal computer and control cabinet, and between the personal computer and exposure stand. The AWS display primarily consists of three windows: - Patient Information Input window . - Exposure Menu Selection window . - . Study window. The user may switch between these windows depending on the operation being performed. The X-ray control panel, which controls and observes the exposure stand, is always displayed in the lower part of each window. This allows setting the exposure conditions and confirming the radiation conditions on a single view.
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    K Number
    K110729
    Device Name
    ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS, USA INC.
    Date Cleared
    2011-09-01

    (169 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJIFILM MEDICAL SYSTEMS, USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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.
    Device Description
    The Aspire HD is an integrated FFDM system combining an X-ray system made by Siemens with Fujifilm's a-Se detector and Acquisition Workstation (AWS). The Aspire HD creates digital mammography images by direct capture of x-ray energy using the a-Se detector is a Fujifilm design utilizing an exclusive dual layer a-Se scintillator with Direct Optical switching circuitry to acquire image data and transfer images to the AWS for automated post processing, technologist preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The Aspire HD provides automated compression and one AEC mode. The Aspire HD Acquisition Workstation (FDR 1000AWS) includes an off the shelf personal computer, the application software, either Microsoft Vista or Windows 7 Operating System, a Smegapixel portrait type monitor, and a hub. The hub transmits signals between the personal computer and control cabinet, and between the personal computer and exposure stand. The AWS display primarily consists of three windows: - Patient Information Input window . - Exposure Menu Selection window t - . Study window. The user may switch between these windows depending on the operation being performed. The X-ray control panel, which controls and observes the exposure stand, is always displayed in the lower part of each window. This allows setting the exposure conditions and confirming the radiation conditions on a single view.
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