RAY-SCAN 64 PET/CT性能测试与临床测试  

Performance Testing and Clinical Trials of RAY-SCAN 64 PET/CT

作　　者：田涧 丁翼晨[1] 杨昆[1] 任秋实[1] 

机构地区：[1]北京大学工学院生物医学工程系,北京100871

出　　处：《中国医疗设备》2015年第2期11-15,6,共6页China Medical Devices

摘　　要：我国PET-CT等高端医疗器械市场被国外产品长期垄断,屈指可数的国产设备远低于市场需求。北京锐视康科技发展有限公司完全掌握了PET/CT的核心器件及整机生产的全套技术,研发成功型号为RAY-SCAN 64 PET/CT,并于2014年2月通过国家食品药品监督管理总局的评审获得注册许可证。严格按照国家标准对该设备进行性能测试,CT的空间分辨率为0.35 mm,PET的最优分辨率达到3.4 mm,不低于市场主流机型的性能指标。在解放军总医院和北京大学附属北京肿瘤医院完成临床测试,分别对头部、胸部、腹部、盆腔和病灶区域的病例进行图像质量分析,并在同等测试条件下与国外两家公司的相似性能设备对比,发现无显著性差异。The PET-CT（Positron Emission Tomography- Computed Tomography） market in China has long been monopolized by imported products.However,current medical equipment designed in China is far from meeting the clinical requirements.ARRAYS Medical Imaging Corporation has a thorough knowledge of the core techniques of PET-CT and production of the integrated system.Its new product,RAY-SCAN 64 PET/CT,demonstrated excellence in the performance test and was successfully validated by China Food and Drug Administration（CFDA） in February 2014.According to the test result,the spatial resolution of CT is 0.3S mm and the best resolution of PET achieves 3.4 mm,which indicates RAY-SCAN 64 PET/CT is comparable with the leading products in the market.In its clinical test,the image quality of brain,chest,abdomen,pelvic and lesion region scans were respectively analyzed by the General Hospital of Chinese People＇s Liberation Army and Beijing Cancer Hospital.Moreover,in comparison with two products from foreign companies under the same testing conditions,RAY-SCAN 64PET/CT demonstrated no significant differences in its clinical performance.

关 键 词：PET-CT 技术参数 性能测试 临床测试 

分 类 号：R197.39[医药卫生—卫生事业管理]