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

    DigitalDiagnost C50

    K Number: K163410 · Decision Jan 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    17
    Review Days
    30

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    Basic Information

    Device Name
    DigitalDiagnost C50
    K Number
    K163410
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Received
    December 5, 2016
    Decision Date
    January 4, 2017
    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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