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510(k) Data Aggregation

    K Number
    K031536
    Device Name
    BRAIN COIL, MODEL 9900GE-64
    Date Cleared
    2003-07-18

    (63 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL MR SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
    Device Description
    Brain Coil, Model # 9900GE-64
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