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

    FUJI UM MAMMO SERIES INTENSIFY SCREENS:

    K Number: K943822 · Decision Aug 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    34
    Applicant Total
    71
    Review Days
    68

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    Basic Information

    Device Name
    FUJI UM MAMMO SERIES INTENSIFY SCREENS:
    K Number
    K943822
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical System U.S.A., Inc.
    Date Received
    June 15, 1994
    Decision Date
    August 22, 1994
    Product Code
    EAM
    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
    EAM Screen, Intensifying, Radiographic

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