AccessGUDID - DEVICE: Hepatoscope (03770023859004)

GUDID

Device Identifier (DI) Information

Brand Name: Hepatoscope
Version or Model: eC5-1 probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: E-SCOPICS

Primary DI Number: 03770023859004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 280265015 *Terms of Use

Device Description: The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device 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 device is composed of: - Hepatoscope App - an external ultrasound E.C5-1 Probe(accessory) dedicated to abdominal imagingand liver imaging. The E.C5-1 Probe is a curvilinear low-frequency ultrasound imaging probe that connects to the Laptop (SelectedHost) via a dedicated USB-C lead cable,consisting of an electrodynamic vibratorlocated at its back, which generates transient vibrations.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60924	Hand-held ultrasound imaging system, body-surface	A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.	Active	false
58711	Hepatic ultrasound elastography system applicator	A non-sterile hand-held device designed to be used for the transcutaneous measurement of liver stiffness based on transient elastography. It includes an ultrasound transducer and an electrodynamic transducer intended to generate a controlled transient vibration that produces a mechanical elastic shear wave propagated through the skin and liver; subsequent ultrasound measurements can be used to calculate a measure of liver stiffness/ultrasonic attenuation of tissues. The device is designed to connect to a control unit and may be available in various forms for different applications [e.g., paediatric, bariatric (obese)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic
IYN	System, Imaging, Pulsed Doppler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4417da8e-ad74-45ca-bca3-8d4702f0306e
Public Version Date: November 20, 2023
Public Version Number: 1
DI Record Publish Date: November 11, 2023