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510(k) Data Aggregation

    K Number
    K170154
    Device Name
    Creavo Vitalscan Magnetocardiograph
    Manufacturer
    Creavo Medical Technologies, Ltd.
    Date Cleared
    2017-10-12

    (267 days)

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

    Creavo Medical Technologies, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Creavo Vitalscan Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
    Device Description
    The Creavo Vitalscan Magnetocardiograph is a transportable device, when not in use, which includes a scan head containing multiple sensors, a moveable arm, electronics, software, user touch screen, power supply, and a rechargeable battery. The wheeled chassis and handles allow the device to be transportable between patient beds. During use, the device is placed adjacent to the patient bed. The color touch screen allows the user to enter patient information (e.g., patient name and scan information) and serves as the visual display unit of the numerical and graphical results during testing. The device also incorporates the use of single use standard ECG electrodes and reusable AHA patient lead wires. The ECG electrodes, are used for gating of the magnetocardiograph signal with the patient's cardiac electrical signal and are used to assist triggering the device electronics and software.
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