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510(k) Data Aggregation

    K Number
    K182571
    Device Name
    CardioFlux with Faraday Analytical Cloud
    Manufacturer
    Date Cleared
    2019-03-15

    (178 days)

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

    Genetesis Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.
    Device Description
    The CardioFlux FAC Magnetocardiograph (MCG) is a biomagnetic sensing device that can record and display the magnetic fields generated by cardiac electrical activity. The CardioFlux FAC hardware connects to the Faraday™ Analytical Cloud (FAC) to allow access to a patient database and software for data analysis. The CardioFlux FAC MCG system consists of a patient table, a 6 x 6 array of optically pumped magnetometers covering roughly an area of 400 square centimeters and a shielding cylinder to reduce ambient electromagnetic interference during a patient scan. CardioFlux FAC is primarily controlled via software applications on a local computer. Data are displayed as 36 superimposed cardiocycles and magnetic field maps.
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