BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cross-Sectional Mammographic Xray System

    PMA: P130025 · Supplement: S002 · Decision Oct 6, 2016
    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 (MODEL CBCT 1000)
    PMA Number
    P130025
    Supplement Number
    S002
    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 6, 2016
    Date Received
    December 28, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the patient table shape; detector upgrade; new quality control phantom and labeling; x-ray generator upgrade; image storage, display server and command processor upgrade; minor replacements of electrical components.

    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