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510(k) Data Aggregation

    K Number
    K051085
    Device Name
    DOPPLER-BOX
    Manufacturer
    COMPUMEDICS GERMANY GMGH
    Date Cleared
    2005-05-05

    (7 days)

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

    COMPUMEDICS GERMANY GMGH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraoperative (specify): N1 (16MHz Probe) Intraoperative Neurological: N (16MHz Probe) Adult Cephalic: N (1MHz TCD Probe); P (2MHz TCD Probe, 2MHz TCD Monitoring Probe) Peripheral Vascular: p3 (Doppler-Box System); P (4MHz Pencil Probe, 8MHz Pencil); N (4MHz Monitoring)
    Device Description
    The Doppler-Box only contains the Doppler hardware, everything else (e.g. QL software, database) is located on a standard PC that is connected to the Doppler-Box. The probes are connected to the Doppler-Box. All sonograms are saved on the PC and can be evaluated, printed and archived. The QL software was especially designed for the Doppler-Box. At the same time, the QL software features an M-Mode. All gates are displayed in one window thus orientation is a lot easier. The Doppler-Box can be used together with the appropriate probes for the entire ultrasound diagnostic (1MHz and 2MHz Probes can work simultaneously, and functional physiological tests can be performed).
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