Device Dossier

MRI system, application program software

Device Dossier for MRI system, application program software (MRI system, application program software, Class IIa, sponsor Emergo). ARTG record, intended…

Intended purpose

Prenuvo Body Composition is a software medical device (SaMD) which is intended for non-invasive fat, muscle and organ quantification. Designed to utilize DICOM-compliant magnetic-resonance image datasets acquired from compatible MR Systems, it displays the internal structure of the body, including the liver. Other physical parameters derived from the images may also be produced. All reported metrics in the Body Composition Report are known in the practice of medicine. Prenuvo Body Composition is indicated for individuals aged 18 years and above.

TGA Public Summary