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510(k) Data Aggregation

    K Number
    K222719
    Device Name
    CX50N
    Manufacturer
    WIDE Corporation
    Date Cleared
    2023-05-09

    (243 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CX50N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
    Device Description
    CX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. CX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
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    K Number
    K222716
    Device Name
    MX50N
    Manufacturer
    WIDE Corporation
    Date Cleared
    2023-05-08

    (242 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.
    Device Description
    MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
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    K Number
    K222717
    Device Name
    CL24N
    Manufacturer
    WIDE Corporation
    Date Cleared
    2022-10-31

    (53 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CL24N LCD Monitor System is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
    Device Description
    CL24N is intended to display high resolution color and gravscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images. EzCal is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. EzCal is packed with the display. While using the CL24N product, use the EzCal S/W provided as a bundle to periodically check whether the product meets the intended use. If the product does not meet the intended use, the product must be returned to the manufacturer or an authorized service center to be calibrated to a product that can be used normally.
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    K Number
    K222722
    Device Name
    CW60N
    Manufacturer
    WIDE Corporation
    Date Cleared
    2022-10-31

    (53 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
    Device Description
    CW60N LCD Monitor is intended to display high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images. EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. EzCal is packed with the display.
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    K Number
    K210493
    Device Name
    CX30N (CX30PQX)
    Manufacturer
    Wide Corporation
    Date Cleared
    2021-04-14

    (54 days)

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

    Wide Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
    Device Description
    CX30N(CX30PQX) is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer. CX30N is basic model and CX30PQX is identical to CX30N, except model name.
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    K Number
    K210491
    Device Name
    CW120N
    Manufacturer
    Wide Corporation
    Date Cleared
    2021-04-08

    (48 days)

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

    Wide Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CW120N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
    Device Description
    CW120N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. CW120N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
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    K Number
    K170781
    Device Name
    MX50N(MX50YQS)
    Manufacturer
    WIDE Corporation
    Date Cleared
    2017-04-04

    (20 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MX50N(MX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
    Device Description
    MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
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    K Number
    K170783
    Device Name
    CX50N(CX50YQS)
    Manufacturer
    WIDE Corporation
    Date Cleared
    2017-03-31

    (16 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CX50N(CX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
    Device Description
    CX50N(CX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for color image display. The WIDE controller board is installed into the PACS workstation computer system to display PACS medical images.
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    K Number
    K160354
    Device Name
    MX50T(MX50TQS)
    Manufacturer
    WIDE CORPORATION
    Date Cleared
    2016-05-02

    (84 days)

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

    WIDE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MX50TQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and breast tomosynthesis applications.
    Device Description
    MX50T(MX50TQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
    Ask a Question
    K Number
    K160353
    Device Name
    MX50N(MX50YQS)
    Manufacturer
    WIDE Corporation
    Date Cleared
    2016-04-22

    (74 days)

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

    WIDE Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MX50N(MX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
    Device Description
    MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
    Ask a Question

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