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510(k) Data Aggregation

    K Number
    K200889
    Device Name
    iMac 27 & PL 4.0
    Manufacturer
    Quantum-Spectra LLC
    Date Cleared
    2020-06-02

    (60 days)

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

    Quantum-Spectra LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apple iMac 27" 5K Retina with PL4.0 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 mammography. The device can NOT be used for a life-support system. The device is intended for prescription use.
    Device Description
    The Apple iMac 27″ 5k Retina with PerfectLum 4.0 (PL 4.0) is a computer with color display for medical viewing. It is combined with QUBYX PerfectLum 4.0 and PerfectLum remote management, a user- friendly 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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