摘要
该文对数字乳腺X射线体层摄影系统注册申报资料技术审评关注点进行了梳理,以期为我国研究人员和生产企业在该类产品申请注册准备资料时提供参考。
In this paper, the focus of technical review of the registration application data of digital Breast Tomosynthesis Mammography System was sorted out, so as to provide reference for researchers and manufacturers in China when applying for registration and preparation of such products.
作者
张宇晶
刘露
许伟
ZHANG Yujing;LIU Lu;XU Wei(Center for Medical Device Evaluation,NMPA,Beijing,100081)
出处
《中国医疗器械杂志》
2019年第4期290-293,共4页
Chinese Journal of Medical Instrumentation
关键词
数字乳腺体层摄影
三维体层成像
二维合成成像
审评关注点
digital breast tomosynthesis
three-dimensional tomography,two-dimensional synthesis
the focus of technical review
