BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    AIXPLORER

    K Number: K132171 · Decision Sep 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    16
    Review Days
    71

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    Basic Information

    Device Name
    AIXPLORER
    K Number
    K132171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Supersonic Imagine
    Date Received
    July 15, 2013
    Decision Date
    September 24, 2013
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Supersonic Imagine

    K Number Device Name
    K242223 SuperSonic HepaVu
    K222191 Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
    K203645 Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
    K202455 Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
    K191007 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
    K180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
    K173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
    K171105 AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
    K161999 Aixplorer
    K142100 AIXPLORER
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