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

    ULTRALITE X-RAY FILM ILLUMINATOR

    K Number: K922848 · Decision Sep 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    102

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    Basic Information

    Device Name
    ULTRALITE X-RAY FILM ILLUMINATOR
    K Number
    K922848
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1890
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A & S Trading Co.
    Date Received
    June 18, 1992
    Decision Date
    September 28, 1992
    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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