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510(k) Data Aggregation

    K Number
    K152847
    Device Name
    DIVA ZSP5812CMI with QUBYX PerfectLum bundle
    Manufacturer
    QUBYX LTD.
    Date Cleared
    2015-11-17

    (49 days)

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

    QUBYX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DIVA ZSP5812CMI can be used only in conjunction with QUBYX PerfectLum. 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 does not contact with the patient. The device is intended for prescription use.
    Device Description
    The DIVA ZSP5812CMI with QUBYX PerfectLum is a 58" 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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