Device Dossier
PET/MRI system
Device Dossier for PET/MRI system (PET/MRI system, Class IIa, sponsor GE Healthcare). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: PET/MRI system
- Sponsor: GE Healthcare
Intended purpose
This device is intended as a diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing