Noninvasive vascular ultrasound system, battery-powered

Intended purpose

The SONOTRAX Series Ultrasonic Pocket Dopplers (hereinafter called "the Doppler") are intended to be used by health care professionals including registered nurses, practical nurses, midwives, and ultrasound technicians, by prescription from licensed physicians in hospitals or clinical environments. This device is intended for use by qualified healthcare professionals within hospital or clinical environments. It is not intended for over-the counter sale or use in home settings by consumers, without the supervision of a qualified healthcare professional." The 2 MHz and/or 3 MHz waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well-being. They can also be used to verify fetal heart viability. The 4 MHz, 5 MHz and/or 8 MHz waterproof vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.