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…
- GMDN category: MRI system, application program software
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.