Hepatic ultrasound elastography generator/analyser

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medwheat Trade Aus Pty Ltd

Class:

Class IIa

Manufactured by:

Wuxi Hisky Medical Technologies Co Ltd Room B401 530 Plaza University Science Park Taihu, International Science & Technology Park Wuxi, Jiangsu Province, 214135 China

Therapeutic area:

58710 - Hepatic ultrasound elastography generator/analyser

Therapeutic indications:

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. It is intended for the non-invasive 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.

Authorization status:

A

Authorization date:

2020-07-16