BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Imaging, Pulsed Doppler, Ultrasonic

    PMA: P940005 · Supplement: S002 · Decision Jul 21, 1998
    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 WITH L12-5 SCANHEAD
    PMA Number
    P940005
    Supplement Number
    S002
    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
    July 21, 1998
    Date Received
    May 30, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design change from HDI 3000(R) Ultrasound System with L10-5 Scanhead to HDI 3000(R) Ultrasound System with L12-5 Scanhead for the indication of an adjunct o mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions. This device provides the physician with additional information to guide a biopsy decision. Utlity of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities. Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies perofrmed on indeterminate 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