Device Dossier
Medical image management system
Device Dossier for Medical image management system (Medical image management system, Class IIa, sponsor Asia Actual). ARTG record, intended purpose, GMDN…
- GMDN category: Medical image management system
Intended purpose
The device is an image processing software intended for use by radiologists and nuclear medicine physicians for noise reduction, sharpening, and resolution improvement of PET images (including PET/CT and PET/MRI) obtained with any kind of radionuclides, e.g. fluorodeoxyglucose (FDG). Enhanced images will be saved in DICOM files and exist in conjunction with original images.