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510(k) Data Aggregation

    K Number
    K102595
    Device Name
    MEDISTIM VERIQC SYSTEM
    Manufacturer
    Date Cleared
    2010-12-27

    (109 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-STIM ASA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are: 1. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery. 2. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures. 3. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures. 4. Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures. 5. Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
    Device Description
    The VeriQC system incorporates several ultrasound modalities that can be used during a variety of surgical interventions. The system utilizes the well established technology of transit-time flow measurements to accurately measure blood flow in veins and arteries intraoperatively. In addition, the system provides ultrasound echocardiography for intraoperative imaging of the cardiovascular circulatory system. The system supports both B-Mode (2D) grayscale imaging, color Doppler (CFM) and pulsed wave Doppler (PW-Doppler). The system also has the ability to connect other external physiological signals such as blood pressure, ECG and other auxiliary signals provided by other monitoring systems. The VeriQC transducer selection includes both transit-time probes for blood flow measurements on various vessel sizes and types as well as an intraoperative imaging probe.
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