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510(k) Data Aggregation

    K Number
    K042221
    Device Name
    CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-12-30

    (135 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coronis 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, including digital mammography, for review by trained medical practitioners. The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
    Device Description
    The Coronis 5MP device is a digital image display system The Coronis 5MP device consists of components to provide high resolution visualization of digital images.
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    K Number
    K042662
    Device Name
    NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-11-22

    (55 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nio 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, excluding digital mammography, for review by trained medical practitioners. The Nio 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The Nio 5MP device is a digital image display system. The Nio 5MP device consists of components to provide high resolution visualization of digital images.
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    K Number
    K042942
    Device Name
    MGP 15 DICOM THEATER
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-11-22

    (28 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MGP 15 Dicom Theater device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. The MGP 15 Dicom Theater is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.
    Device Description
    The MGP 15 Dicom Theater device is a digital image display system The MGP 15 Dicom Theater consists of components to provide high resolution visualization of digital images.
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    K Number
    K042660
    Device Name
    NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-11-19

    (52 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nio 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, excluding digital mammography, for review by trained medical practitioners. The Nio 2MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The Nio 2MP device is a digital image display system The Nio 2MP device consists of components to provide high resolution visualization of digital images.
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    K Number
    K042661
    Device Name
    NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-11-19

    (52 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nio 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, excluding digital mammography, for review by trained medical practitioners. The Nio 3MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The Nio 3MP device is a digital image display system The Nio 3MP device consists of components to provide high resolution visualization of digital images.
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    K Number
    K041508
    Device Name
    BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-08-27

    (81 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coronis 5MP HD display is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is specifically designed for digital mammography applications.
    Device Description
    The Coronis 5MP HD is a diagnostic display
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    K Number
    K033859
    Device Name
    BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-06-02

    (174 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.
    Device Description
    The MGD 521M device is a digital image display system, image monitor/display, and others workstation, image processing
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    K Number
    K033006
    Device Name
    MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-04-20

    (270 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIVD 1218 18 Inch Grayscale Display Module is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The MIVD 1218 is a diagnostic display. The MIVD 1218 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
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    K Number
    K033005
    Device Name
    MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-04-19

    (207 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MFGD 1318 18 Inch 1 Megapixel Grayscale LCD Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The MFGD 1318 is a diagnostic display. The MFGD 1318 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
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    K Number
    K033104
    Device Name
    MGD 2621P MEDICAL GREYSCALE DISPLAY
    Manufacturer
    BARCO NV BARCOVIEW
    Date Cleared
    2004-04-19

    (203 days)

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

    BARCO NV BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MGD 2621P Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The MGD 2621P is a diagnostic display
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