BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇴 Norway

    Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System

    K Number: K150087 · Decision Mar 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    10
    Review Days
    48

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    Basic Information

    Device Name
    Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
    K Number
    K150087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Vingmed Ultrasound AS
    Date Received
    January 15, 2015
    Decision Date
    March 4, 2015
    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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    Other Clearances by Ge Vingmed Ultrasound AS

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