RESONANCE HEALTH ANALYSIS SERVICES PTY LTD V1.0.0 HepaFat-AI
Company Name
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Catalog Number
V1.0.0
Description
Standalone software platform designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. HepaFat-AI is intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF). It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.When interpreted by a trained physician, the results provide information that can aid in diagnosis.HepaFat-AI is indicated to:• Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease;• Monitor liver fat content in patients undergoing weight loss management;• Aid in the assessment and screening of living donors for liver transplant.
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Additional Details
Device Identifier
09355529000019
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
No
Barcode Mapping
| Unit of Measurement | Eaches | GTIN |
|---|---|---|
| Each | 1 | 09355529000019 |

