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

    ASPIRE Cristalle

    K Number: K173132 · Decision Oct 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    54
    Applicant Total
    39
    Review Days
    28

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    Basic Information

    Device Name
    ASPIRE Cristalle
    K Number
    K173132
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1715
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical Systems U.S.A, Inc.
    Date Received
    September 29, 2017
    Decision Date
    October 27, 2017
    Product Code
    MUE
    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
    MUE Full Field Digital, System, X-Ray, Mammographic

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