6168105CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Road Jiading District 210807 Shanghai China |
| INTEGRATED CT/PET SYSTEMS (Z110203, Class IIb) | |
| Device Name: uMI 780 PET/CT System | Intended Purpose: The product is a PET/CT system designed for producing attenuation corrected PET images. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body, including the whole body, brain, head and neck, heart, lung, breast, gastrointestinal, urinary system and genital organ, musculoskeletal systems, and others organ or systems. |
| Device Name: uMI Panorama 35 PET/CT system uMI Panorama 28 PET/CT system uMI Panorama GS PET/CT system | Intended Purpose: The system is 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 the whole body, brain, head and neck, heart, lung, breast, gastrointestinal, urinary system and genital organ, musculoskeletal systems, and others organ or systems. |