BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    SMART MOTORIZED VIEWER

    K Number: K973965 · Decision Dec 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    56

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    Basic Information

    Device Name
    SMART MOTORIZED VIEWER
    K Number
    K973965
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1890
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smartlight, Ltd.
    Date Received
    October 17, 1997
    Decision Date
    December 12, 1997
    Product Code
    IXC
    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
    IXC Illuminator, Radiographic-Film

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