Device Category Dossier

MRI system, application program software

Device Category Dossier for MRI system, application program software. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Software medical devices utilise

DICOM-compliant magnetic-resonance image datasets to perform non-invasive quantification of body composition including fat, muscle and organ measurements. These devices are indicated for individuals aged 18 years and above and support clinical evaluation of liver tissue properties including iron concentration and fat fraction measurements.