6127557CE01
| Company | MinFound Medical Systems Co., Ltd. |
| Address | No.851, Yinhai Road, Xiasha Street, Qiantang District Hangzhou City, 310018 Zhejiang P.R. China |
| Directive | Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III |
| INTEGRATED SYSTEMS FOR CT/PET (Z110203, class IIb) | |
| Group of Devices: Positron Emission Tomography and Computed Tomography Systems | Intended Purpose: The product combines the positron emission tomography computed (PET) subsystem and the X-ray computed tomography (CT) subsystem, which provides the registration and fusion of anatomical and physiological information. The generated images are often used in examination and evaluation of disease such as tumors, nervous systems, provided with functional and anatomical information of human organs and tissues. The CT subsystem can provide the attenuation correction diagram for PET images and the anatomical reference for PET and CT fused images. The CT subsystem can also be independently used for diagnosis. |
| This certificate is valid until | 1 May 2028 |