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510(k) Data Aggregation

    K Number
    K191705
    Device Name
    OptikView GUP2103CMI
    Manufacturer
    The Linden Group Corp
    Date Cleared
    2020-03-16

    (264 days)

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

    The Linden Group Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OptikView GUP2103CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The device can NOT be used in primary image diagnosis in mammography. The device can NOT be used for a life-support system. The device is intended for prescription use.
    Device Description
    The OptikView GUP2103CMI with QUBYX PerfectLum is a 21" color display for medical viewing. It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.
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    K Number
    K160328
    Device Name
    DIVA ZSP2105CMI with QUBYX PerfectLum bundle
    Manufacturer
    THE LINDEN GROUP CORP.
    Date Cleared
    2016-02-25

    (20 days)

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

    THE LINDEN GROUP CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners. The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum. The device can not be used for a life-support system. The device does not contact with the patient. The device is intended for prescription use.
    Device Description
    The DIVA ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.
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