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

    DUS-6000 Digital Ultrasonic Diagnostic Imaging System

    K Number: K172931 · Decision Dec 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    345
    Registration Numbers
    346
    Same Product Code
    883
    Applicant Total
    1
    Review Days
    67

    Basic Information

    Device Name
    DUS-6000 Digital Ultrasonic Diagnostic Imaging System
    K Number
    K172931
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Instrumentations, Inc.
    Date Received
    September 25, 2017
    Decision Date
    December 1, 2017
    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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