BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P010034 · Supplement: S003 · Decision Aug 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY
    PMA Number
    P010034
    Supplement Number
    S003
    Device Class
    FDA Class 2
    Product Code
    MYN
    Generic Name
    Analyzer, medical image
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 11, 2003
    Date Received
    February 27, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SECOND LOOK DIGITAL CAD SYSTEM FOR GEMS SENOGRAPHIE 2000D FULL FIELD DIGITAL MAMMOGRAPHY. THE CHANGES INCLUDE SOFTWARE UPGRADE TO ACCOMMODATE DIGITAL IMAGE PROCESSING AND AN ADDITION OF RACK MOUNTABLE HARDWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY AND IS INDICATED FOR IDENTIFICATION AND MARKING REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM GENERAL ELECTRIC MEDICAL SYSTEMS SENOGRAPHIE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.

    Classifications

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

    Product Code Device Name
    MYN Analyzer, Medical Image