SUPERSONIC IMAGINE, INC. SSIP93164 SLH20-6 Gen III®

The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.In particular, the device is intended to provide:Linear distance measurements of anatomical structures,Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies,Measurement of brightness ratio between structures and in particular between the liver and the kidney,Estimates of speed of sound in the liver.The device is composed of:- Hepatoscope App- an external ultrasound E.C5-1 Probe(accessory) dedicated to abdominal imagingand liver imaging. The E.C5-1 Probe is a curvilinear low-frequency ultrasound imagingprobe that connects to the Laptop (SelectedHost) via a dedicated USB-C lead cable,consisting of an electrodynamic vibratorlocated at its back, which generates transientvibrations.