Device Dossier
Medical image management system application software
Device Dossier for Medical image management system application software (Medical image management system application software, Class IIa, sponsor Philips…
- GMDN category: Medical image management system application software
Intended purpose
To be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.