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

    BUCKYMATIC AUTOMATIC CHEST FILM CHANGER

    K Number: K925598 · Decision Feb 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    25
    Applicant Total
    13
    Review Days
    88

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    Basic Information

    Device Name
    BUCKYMATIC AUTOMATIC CHEST FILM CHANGER
    K Number
    K925598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1860
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acoma Medical Imaging, Inc.
    Date Received
    November 5, 1992
    Decision Date
    February 1, 1993
    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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