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Hepatus 7/Hepatus 6/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 57/Fibrous 7/ Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric and Peripheral vessel exams.

It is intended to provide 50 Hz shear wave speed measurements (ViTE: Visual Transient Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body.

The ViTE and stiffness, and LiSA may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of liver.

The ViTE and stiffness may be used as an aid to clinical management of pediatric patients with liver disease. The clinical applications include:Fetal, Abdominal, Pediatric and Peripheral vessel.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B.M.PW Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging(Contrast agent for Liver), ViTE, LiSA and Combined mode:B+M, PW+M, Color+B. Power+B. PW+Color+B. Power+PW+B.

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, Color-mode, Color M-mode, Power/Dirpower mode, THI, Biopsy Guidance, ViTE, Contrast imaging or the combined mode (i.e. B/M-Mode).

This system is a Track 3 device that employs an array of probes that include convex array and phased array.

The provided text only contains regulatory information about clearances for the Hepatus 7/Hepatus 6/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document explicitly states "Clinical Tests: Not Applicable."

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