AmCAD-UV
AmCad BioMed CorporationAmCAD-UV is a software tool designed to analyze flow Doppler ultrasound images by classifying ultrasonic color intensity data into different pulsatile signals. It helps clinicians visualize and evaluate vascular pulsatility by providing color-coded images and trend charts of pulsatile signals, although it is not intended for primary diagnostic use by itself.
Intended Use
AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation.
Technology
AmCAD-UV quantifies color pixels within the scanning area of flow Doppler ultrasound images based on color intensities and groups them by similar periodic pulsatile waveforms to generate classified color-coded pulsatile signal images for vascular pulsatility evaluation. It provides dual image views, trend charts, and exports quantified values and images in common formats.
Performance
Software verification and performance validation testing, including unit, integration, and system tests were conducted to ensure the device's safety and effectiveness. Human validation studies showed the device can visualize and quantify primary, secondary, and unidentified pulsatile signals in flow Doppler ultrasound images. The device labeling includes operating instructions and warnings to ensure safe use.
Predicate Devices
No predicate devices specified
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