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510(k) Data Aggregation

    K Number
    K131601
    Device Name
    DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
    Manufacturer
    QUBYX LIMITED
    Date Cleared
    2014-07-07

    (399 days)

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

    QUBYX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, for review and analysis by trained medical practitioners. The DELL U3014 must only be used in conjunction with QUBYX PerfectLum. The device must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system and does not contact with the patient.
    Device Description
    The DELL U3014 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 2560x1600 resolution with an adjustable Look Up Table and a 10 bit panel. 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
    K111385
    Device Name
    DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
    Manufacturer
    QUBYX LIMITED
    Date Cleared
    2012-01-30

    (258 days)

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

    QUBYX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners. The DELL UltraSharp U3011 must only be used in conjunction with QUBYX PerfectLum 3.0 These devices must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system.
    Device Description
    The DELL UltraSharp U3011 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 4 mega pixel (2560x1600) resolution with a adjustable Look Up Table and a 10 bit Panel. It is combined with QUBYX PerfectLum 3.0 and PerfectLum remote QA, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows to set the display function to DICOM, display testpattern and perform acceptance and constancy tests.
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