Device Dossier

MRI system, application program software

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

Intended purpose

This software is intended for use in post-acquisition quantitative analysis of MRI brain studies.It performs automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. The software is intended to automate the current manual and semi-manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR Images. It is intended to provide neurologists, radiologists, and clinical researchers with a convenient and cost-effective means to measure the volumes of segmentable brain structures from MR images. It is intended for use in a professional medical technology setting."

TGA Public Summary