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

    FUJI ULTIMA EC-MA CASSETTE

    K Number: K942481 · Decision Jul 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    50
    Applicant Total
    70
    Review Days
    65

    Basic Information

    Device Name
    FUJI ULTIMA EC-MA CASSETTE
    K Number
    K942481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Date Received
    May 25, 1994
    Decision Date
    July 29, 1994
    Product Code
    IXA
    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
    IXA Cassette, Radiographic Film

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