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510(k) Data Aggregation

    K Number
    K033488
    Device Name
    CMI MAGNETOCARDIOGRAPH
    Manufacturer
    CMI CARDIOMAG IMAGING INC
    Date Cleared
    2004-07-07

    (246 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMI CARDIOMAG IMAGING INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CMI Magnetocardiograph is intended for use as a tool that non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
    Device Description
    This device integrates an array of magnetic detectors with data acquisition hardware/software for the purpose of measuring the magnetic signals generated by the electrical current flowing in the heart. The detectors are housed in a vertically adjustable holder. The patient bed moves horizontally in orthogonal directions allowing the acquisition of multiple datasets for different locations above the torso. Three standard ECG electrodes are placed on each wrist and one ankle of the subject to provide a reference signal for synchronization of multiple MCG datasets. The MCG data is preprocessed and displayed as either real time traces, averaged traces, or as multi-dimensional color maps.
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