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

    Revolution Ascend Sliding

    K Number: K233749 · Decision Feb 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    10
    Review Days
    92

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    Basic Information

    Device Name
    Revolution Ascend Sliding
    K Number
    K233749
    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
    November 22, 2023
    Decision Date
    February 22, 2024
    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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