BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UNIVERSAL STAND FOR FILM CHANGER

    K Number: K862575 · Decision Jul 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    25
    Applicant Total
    48
    Review Days
    7

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    Basic Information

    Device Name
    UNIVERSAL STAND FOR FILM CHANGER
    K Number
    K862575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1860
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Canon USA, Inc.
    Date Received
    July 7, 1986
    Decision Date
    July 14, 1986
    Product Code
    KPX
    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
    KPX Changer, Radiographic Film/Cassette

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