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…

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.

TGA Public Summary