[FibroScan.com] - Revision date [09/30/2014] - FibroScan® is a class IIa medical device according to Directive EC/93/42 and is manufactured by Echosens. Assessment of its conformity with the essential requirements of the Directive EC/93/42 is established by the LNE-G-MED (n°0459) - France -. FibroScan® is indicated for the noninvasive measurement of liver stiffness (E) and controlled attenuation parameter (CAP) in adult humans. It is expressly recommended to carefully read the guidance within the users’ guide and labeling of the device. FibroScan® examination must only be performed by operators certified by the manufacturer or its accredited local representative. The values obtained with FibroScan® must be interpreted by a physician experienced in dealing with liver disease, taking into account the complete medical record of the patient. In France, liver stiffness measurement by FibroScan® is reimbursed by national Social Security medical insurance, in some circumstances and under certain conditions: see terms on the ameli.fr website.FibroScan® and its probes (M+ and XL+) is a class II medical device according to the Code of Federal regulation (21 CFR Sections 892.1560 and 892.1570). The FibroScan® system is intended to provide 50Hz shear wave speed measurements through internal structure of the body. FibroScan® is indicated for noninvasive measurement of shear wave speed at 50Hz in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.