Hepatoscope

Organization name

E-SCOPICS

SRN

FR-MF-000019303

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 4 countries total.

Trade name

Hepatoscope

UDI-DI code

03770023859011

Basic UDI-DI

3770023859410_0001NQ

Reference / catalog number

410_0001

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

As part of the ES-Series ultrasound diagnostic systems, the Hepatoscope App using the e.C5-1 probe is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended 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 tissue brightness parameters in the liver at selected ultrasound frequencies, - 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 tissue brightness parameters, 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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