BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cross-Sectional Mammographic Xray System

    PMA: P130025 · Supplement: S004 · Decision Oct 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Cross-Sectional Mammographic Xray System
    Trade Name
    Koning Breast CT, KBCT (Model CBCT1000)
    PMA Number
    P130025
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    OLQ
    Generic Name
    Cross-sectional mammographic xray system
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 12, 2023
    Date Received
    July 26, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for (1) modifications to hardware components, specifically the Xray Generator, Tube, and Detector, and (2) software enhancements such as improved GUI features for both the console and viewer, transition from touchscreen to hard buttons for motion control, and additional features tailored for health care provider convenience.

    Classifications

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

    Product Code Device Name
    OLQ Cross-Sectional Mammographic Xray System