Hepatoscope

Primary DI

03770023859011

Basic UDI-DI Code

37700238590NQ

Reference

V2

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

E-SCOPICS

Hepatoscope Indications for Use: As part of the ES-Series ultrasound diagnostic systems, the Hepatoscope App using the e.C5-1 probe shall be indicated for imaging of anatomical structures in the abdomen and measurements of physical properties. In particular for the liver and the spleen, the Hepatoscope App shall be indicated to provide: • Linear distance measurements of anatomical structures, • Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, • Estimates of ultrasound attenuation coefficient in the liver at 3.5 MHz, • Measurement of brightness ratio between structures and in particular between the liver and the kidney, • Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound beam attenuation, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).