Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121825
    Device Name
    CS-MAG II
    Date Cleared
    2013-03-11

    (263 days)

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

    BIOMAGNETIK-PARK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BMP MCG CS-MAG II Magnetocardiograph is intended for use as tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
    Device Description
    The BMP MCG CS-MAG II system will be used for diagnostic purposes in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, multichannel body surface mapping technique to record biomagnetic signals from the heart generated by the same ionic currents underling the electrocardiogram. Compared to electrocardiography (ECG), MCG has similar morphological features such as T-, P-, and Q-waves, and the QRS complex. The advantages of MCGs over traditional ECGs are increased sensitivity to weak signals, lack of distortion from conductivity in body tissues, and presentation of direct current (DC) component signals and primary currents.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1