BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cross-Sectional Mammographic Xray System

    PMA: P130025 · Decision Jan 14, 2015
    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 CBCT1000)
    PMA Number
    P130025
    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
    January 14, 2015
    Date Received
    November 25, 2013
    Expedited Review
    N
    Docket Number
    15M-0200

    Advisory Committee Statement

    APPROVAL FOR THE KONING BREAST CT (MODEL CBCT 1000). THIS DEVICE IS INDICATED AS FOLLOWS: KONING BREAST CT (CBCT1000) IS A CONE BEAM COMPUTED TOMOGRAPHY SYSTEM INTENDED TO PROVIDE THREE DIMENSIONAL IMAGES FOR DIAGNOSTIC IMAGING OF THE BREAST. KONING BREAST CT SHOULD BE READ ALONG WITH STANDARD 2-VIEW MAMMOGRAPHY (CC AND MLO VIEWS).

    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