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    K Number
    K160078
    Device Name
    Vivid T8
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnotics, L
    Date Cleared
    2016-03-10

    (56 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Ultrasound and Primary Care Diagnotics, L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vivid T8 is a multipurpose cardiovascular ultrasound system intended for diagnostic ultrasound imaging and fluid flow analysis. The system supports the following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular. Adult Cephalic. Neonatal Cephalic. Musculoskeletal Superficial/ Conventional, Transcranial, Transrectal, Transvaginal and Transesophageal.
    Device Description
    The Vivid T8 is the full featured cardiovascular diagnostic ultrasound system designed for cardiac and shared service imaging which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel
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