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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM

    K Number: K093849 · Decision Jan 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    24
    Review Days
    34

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    Basic Information

    Device Name
    ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
    K Number
    K093849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medison Co., Ltd.
    Date Received
    December 16, 2009
    Decision Date
    January 19, 2010
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 Medison Co., Ltd.

    K Number Device Name
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