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510(k) Data Aggregation

    K Number
    K071166
    Device Name
    UNIWEB, VERSION 5.0
    Date Cleared
    2007-07-23

    (88 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations. UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats. UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities. UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting. UniWeb™ will be utilized only on FDA approved monitors used for mammography. Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians. This product will only use lossless compression or no compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals.
    Device Description
    UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
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    K Number
    K062743
    Device Name
    UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
    Date Cleared
    2006-10-31

    (47 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K023394
    Device Name
    UNISIGHT SYSTEM WITH UNIGATE
    Date Cleared
    2003-01-07

    (90 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UniSight™ system with UniGate™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer network at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
    Device Description
    Not Found
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