BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P160031 · Decision Jan 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
    PMA Number
    P160031
    Device Class
    FDA Class 3
    Product Code
    OTE
    Generic Name
    Digital breast tomosynthesis
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 10, 2017
    Date Received
    August 1, 2016
    Expedited Review
    N
    Docket Number
    17M-0181

    Advisory Committee Statement

    Approval for the Aspire Cristalle Digital Breast Tomosynthesis Option. The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images, and is intended for use in the screening and diagnosis of breast cancer. A screening examination may consist of sets of CC and MLO images acquired in: 1) the FFDM mode only, or 2) an FFDM image set and a DBT image set acquired in the ST (standard) mode. The FFDM image set and the DBT image set must be acquired with N-mode dose setting, and may be acquired in one compression (Tomo Set mode) or separate compressions (FFDM and DBT modes).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OTE Digital Breast Tomosynthesis