Device Dossier

MRI system, application program software

Device Dossier for MRI system, application program software (MRI system, application program software, Class IIa, sponsor Resonance Health Analysis…

Intended purpose

HepaFatScan is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading. HepaFatScan is a software as medical devices that are indicated for the non-invasive evaluation of liver tissue by utilising magnetic resonance images to evaluate the difference in amplitude of magnetic resonance signals from 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.

TGA Public Summary