BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Revolution Maxima, Revolution Ace

    K Number: K192686 · Decision Oct 24, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    795
    Applicant Total
    1
    Review Days
    28

    Basic Information

    Device Name
    Revolution Maxima, Revolution Ace
    K Number
    K192686
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Hangwei Medical Systems Co.,Ltd.
    Date Received
    September 26, 2019
    Decision Date
    October 24, 2019
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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