BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS

    K Number: K991302 · Decision Jun 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    46

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    Basic Information

    Device Name
    SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
    K Number
    K991302
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1890
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smartlight, Inc.
    Date Received
    April 16, 1999
    Decision Date
    June 1, 1999
    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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