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

    I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

    K Number: K103608 · Decision Dec 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    2
    Review Days
    18

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    Basic Information

    Device Name
    I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
    K Number
    K103608
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ellex, Inc.
    Date Received
    December 9, 2010
    Decision Date
    December 27, 2010
    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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