BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Vscan Air

    K Number: K250087 · Decision May 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    25
    Review Days
    107

    Basic Information

    Device Name
    Vscan Air
    K Number
    K250087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Medical Systems Ultrasound and Primary Care Diagnostics
    Date Received
    January 14, 2025
    Decision Date
    May 1, 2025
    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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