Device Dossier

HAL system - Ultrasound system, non-imaging, Doppler blood-flow measurement

Device Dossier for HAL system - Ultrasound system, non-imaging, Doppler blood-flow measurement (Ultrasound system, non-imaging, Doppler blood-flow…

Intended purpose

A portable or stationary ultrasound system that does not produce 2 or 3-D anatomical images, used to evaluate various blood flow related parameters in the arteries and veins. It is used to output either audible information and/or produce visual displays of Doppler shift frequencies as a function of time (a spectral display) allowing diagnosis of normal versus abnormal blood flow patterns. This device group includes both continuous-wave and pulsed-wave Dopplers.

TGA Public Summary