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

    FS-500DDR Medical Radiographic X-Ray System

    K Number: K152813 · Decision Dec 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    1
    Review Days
    431

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    Basic Information

    Device Name
    FS-500DDR Medical Radiographic X-Ray System
    K Number
    K152813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orich Medical Equipment (Tianjin) Co., Ltd.
    Date Received
    September 28, 2015
    Decision Date
    December 2, 2016
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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