BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P160031 · Supplement: S003 · Decision Sep 30, 2020
    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 (DBT) Option
    PMA Number
    P160031
    Supplement Number
    S003
    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
    September 30, 2020
    Date Received
    July 2, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) the integration of the DBT Option as a software module on the 510(k) cleared ASPIRE Bellus II (K171463) for the reconstruction of tomosynthesis acquisitions, and 2) an updated Indications for Use to include the optional integration of the DBT Option software module on the cleared ASPIRE Bellus II and its functionality.

    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