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510(k) Data Aggregation

    K Number
    K083824
    Device Name
    HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
    Manufacturer
    HUMANSCAN COMPANY, LTD.
    Date Cleared
    2009-02-10

    (50 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUMANSCAN COMPANY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Humanscan M5S-D is phased array ultrasound transducer, for the GE Vivid E9 Ultrasound System, and indicated primarily for ultrasonic evaluation of cardiology conditions. It is also indicated for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic, and urology/prostate use.
    Device Description
    The Cardiac Ultrasound Transducer (M5S-D) is a matrix array probe with 192 elements for GE's ultrasound diagnostic system, Vivid E 9.
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