uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Intended Use

The uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body, including whole body, brain, head and neck, heart, lung, breast, gastrointestinal, urinary system and genital organ, musculoskeletal systems, and others. When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the uMI Panvivo generates images depicting the distribution of these radiopharmaceuticals. The images can serve as an aid in detection, localization, evaluation, diagnosis, staging, re-staging, monitoring, and/or follow-up of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or diseases, in clinical areas such as oncology, infection and inflammation, and neurology. The CT system can be used for low dose CT lung cancer screening for early detection of lung nodules that may represent cancer.