Device Dossier

Noninvasive vascular ultrasound system, battery-powered

Device Dossier for Noninvasive vascular ultrasound system, battery-powered (Noninvasive vascular ultrasound system, battery-powered, Class IIa, sponsor…

Intended purpose

The SD3 Series Ultrasonic Pocket Dopplers are intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHzand3MHzwaterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. Specifically, the 3 MHz probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. 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.

TGA Public Summary