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Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.

Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue stiffness in spleen.

Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis in the human body (including abdominal applications) in B, M, CFM, PWD, B/B, 4B, B+M, B+CFM, B+PWD, and B+CFM+PWD modes.

The system must be operated by qualified and appropriately trained medical professionals in a professional healthcare facility environment.

The subject system is a general purpose, software-controlled, diagnostic ultrasound system. It is composed of a complex probe, an imaging probe, a main unit, a power cord, a foot switch, two fuses and a protective earth wire. The complex probe is a convex array probe used for elasticity measurement and ultrasound imaging, and the imaging probe is also a convex array probe used for ultrasound imaging. The system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator in the complex probe produces low-frequency shear waves at 50 Hz or 100HZ that travel through the skin and intercostal space into the liver or spleen respectively. The propagation speed of the shear wave is captured by complex probe using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B, M, CFM, PWD modes. The system uses imaging probe and complex probe with a frequency range of 2.5MHz to 5.0 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the Transient Elastography examination.

There are a total of 6 models in this product, all of which share the same intended use, physical design and principle of technology. The only differences among these models are software functions configuration and availability of imaging probe.

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