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…
- GMDN category: MRI system, application program software
Intended purpose
NeoSoft’s MRI system application software product is an application program package intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.