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

The ImageR2 (R2-MRI Analysis System) is a standalone software as a medical device that is designed to be used to analyse MR images acquired with a specific imaging protocol for the evaluation of the MRI property R2 or R2* with the capability of covering the full spectrum of R2 or R2* (related to tissue iron concentration) clinically observed. The ImageR2 (R2-MRI Analysis System) is indicated for the evaluation of, liver R2 and liver iron concentration and cardiac R2* from MRI images.

TGA Public Summary