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Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50Hz 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 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 of the human body. It can be used in the following applications: Abdominal, including locating of the liver. The system must be operated by qualified and appropriately trained healthcare professionals in a professional healthcare facility environment.

The proposed device is a general purpose, mobile, software-controlled, diagnostic ultrasound system. It consists of a fibrosis scanning probe, an imaging probe, a main unit, a probe holder, an AC/DC adapter and a foot switch. The fibrosis scanning probe is a single element probe used for elasticity measurement, while the imaging probe is a convex probe used for ultrasound imaging. The system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator in the fibrosis scanning probe produces low-frequency shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is captured 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 with nominal Frequency of 2.5-4.5 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 9 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.

Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz 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 (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter ( UAP ). The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver. Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the liver.

The Shear Wave Quantificational Ultrasound Diagnostic System, Models: FT9000, FT100 and Mini800, iLivTouch brand, is a general purpose, mobile, software-controlled, diagnostic ultrasound system. FT9000 is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging. But the model FT100 and Mini800 is equipped with only one fibrosis scanning probe.FT100 and Mini800 have the same appearance structure and hardware, but the software is different. Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 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.

Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease. Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal.

The Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. The system is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging. Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness in liver. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 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.