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510(k) Data Aggregation

    K Number
    K232823
    Device Name
    MCG-S (AM1000)
    Manufacturer
    Date Cleared
    2024-04-05

    (205 days)

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

    AMCG Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AM1000 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
    AMCG's MCG-S will be used for purpose of measurement and analysis in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, multichannel body surface mapping technique to record biomagnetic signals of X- and Y-components from the heart generated by the same ionic currents underling the electrocardiogram. This system consists of Dewar with 96-channel SQUIDs, gantry, electronics, power supply device, and software. 48 of these SQUID sensors are used for detecting the X-components, and the remaining 48 sensors are for the Y-components of the magnetic field. The device does not measure and/or display the magnetic field in the Z-component. The system increases the output signal of the SQUID by applying the DROS (Double Relaxation Oscillation SQUID) method to increase the measurement sensitivity of the cardiac magnetic field signal, and a wide range of channel area is applied to measure the magnetic field area throughout the heart within a short time. In addition, in order to minimize the mechanical vibration of the sensor, the sensor is installed in a vacuum area, and Dewar, which has excellent noise shielding and insulation performance, is applied. The system is controlled through noise-free optical fiber signals and can control, measure, process and analyze signals through software.
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