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510(k) Data Aggregation

    K Number
    K053648
    Device Name
    PIONEER TC8080, COMPANION III
    Manufacturer
    VIASYS NEURO CARE
    Date Cleared
    2006-01-24

    (25 days)

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

    VIASYS NEURO CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (Transcranial and Intracranial Doppler Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection, Extracranial carotid monitoring), Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
    Device Description
    The modified Pioneer TC 8080 and Companion III are Doppler ultrasound systems. Both systems utilize the well-understood principle of Doppler shift to detect the flow of blood within the body. The ultrasound probe generates ultrasonic energy, which is coupled to the body. The ultrasonic energy, which is reflected from the moving blood in blood vessels and the returning signal, is detected as a frequency shifted signal. The amount of frequency shift is a function of the velocity of the flowing blood. These systems generate, transmit and receive an ultrasonic signal, then process and display the Doppler signal returning from the anatomy. The Pioneer TC8080 can be used with up to four Doppler ultrasound probes simultaneously. The Companion III, applying the same software and hardware as the Pioneer TC8080, can be used with up to two Doppler ultrasound probes simultaneously.
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