Device Dossier
Omni Legend - Combination diagnostic imaging system, PET/CT
Device Dossier for Omni Legend - Combination diagnostic imaging system, PET/CT (Combination diagnostic imaging system, PET/CT, Class IIb, sponsor GE…
- GMDN category: Combination diagnostic imaging system, PET/CT
- Sponsor: GE Healthcare
Intended purpose
This system is intended for CT attenuation corrected (CTAC), anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging.