BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Imaging, Pulsed Doppler, Ultrasonic

    PMA: P940005 · Supplement: S001 · Decision Dec 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211

    Basic Information

    Device Name
    System, Imaging, Pulsed Doppler, Ultrasonic
    Trade Name
    HDI 3000 ULTRASOUND SYSTEM
    PMA Number
    P940005
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    IYN
    Generic Name
    System, imaging, pulsed doppler, ultrasonic
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 1996
    Date Received
    July 25, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN CHANGE FROM THE ULTRAMARK(R) 9 ULTRASOUND SYSTEM WITH HIGH DEFINITION(TM) IMAGING (HDI(TM)) AND L10-5 SCANHEAD TO A HDI 3000(R) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD FOR THE INDICATION OF AN ADJUNCT TO MAMMOGRAPHY AND PHYSICAL BREAST EXAMINATION, TO PROVIDE A HIGH DEGREE OF PHYSICIAN CONFIDENCE IN DIFFERENTIATING BENIGN FROM MALIGNANT OR SUSPICIOUS BREAST LESIONS.

    Classifications

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

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic