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,…
- GMDN category: MRI system, application program software
- Sponsor: GE Healthcare
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."