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

    MOBIUS ULTRASOUND IMAGING SYSTEM

    K Number: K102153 · Decision Jan 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    345
    Registration Numbers
    346
    Same Product Code
    883
    Applicant Total
    1
    Review Days
    174

    Basic Information

    Device Name
    MOBIUS ULTRASOUND IMAGING SYSTEM
    K Number
    K102153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MOBISANTE, INC.
    Date Received
    July 30, 2010
    Decision Date
    January 20, 2011
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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