BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P160031 · Supplement: S001 · Decision Feb 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    ASPIRE Cristalle Breast Tomosynthesis System
    PMA Number
    P160031
    Supplement Number
    S001
    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
    February 8, 2019
    Date Received
    October 23, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the implementation of the synthesized 2D (S-View) image, changing the image processing in DBT reconstruction to iterative super-resolution reconstruction (ISR), applying new image processing, Dynamic Visualization II for mammography (DVIIm), to DBT and synthesized 2D images, and related changes in the indications for use (IFU).

    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