The intended use for the FibroScan family of products.
The FibroScan intended use
The intended use/indications for use for the FibroScan are as follows:
The FibroScan Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP™: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
Additionally, the FibroScan technology complies with all applicable rules governing the level of energy applied and absorbed to the human body, including mechanical indexes and heat dissipation.
Clinical practice guidelines
FibroScan, patented VCTE™ technology is the reference for the non-invasive assessment of liver disease in many internationally recognized treatment guidelines, across specific etiologies of Liver Disease.Request to be contacted