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…

Intended purpose

To be used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. It displays coregistered PET, SPECT, and CT images, along with output from quantification of activities reflecting regional concentrations of FDG, amyloid imaging agents, SPECT perfusion and dopamine transporter radiotracers, relative to activities in any of several userselected reference regions or whole brain. It provides for displaying and quantifying the regional differences between two PET or SPECT brain studies for the same patient, or the levels of amyloid imaging agents retained in specified brain regions of a patient, and for assisting the user in the examination of brain scans acquired for assessing differential diagnosis of neurodegenerative processes underlying symptoms of cognitive and movement disorders by comparing regional activity values to each other and to those in brain scans acquired for asymptomatic control subjects.

TGA Public Summary