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510(k) Data Aggregation
K Number
K051085Device Name
DOPPLER-BOX
Manufacturer
COMPUMEDICS GERMANY GMGH
Date Cleared
2005-05-05
(7 days)
Product Code
IYN
Regulation Number
892.1550Why 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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