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中国医疗器械杂志 2019, Vol. 43 Issue (5) :359-361    DOI: 10.3969/j.issn.1671-7104.2019.05.013
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计算机辅助诊断软件产品分类管理研究  
戎善奎1,江潇1,冯建2,张春青1,余新华1
1 中国食品药品检定研究院(国家药品监督管理局医疗器械标准管理中心),北京市,102629
2 北京市医疗器械检验所,北京市,101111
Researching on the Classification of Computer Aided Diagnosis/Detection Software
RONG Shankui1, JIANG Xiao1, FENG Jian2, ZHANG Chunqing1, YU Xinhua1
1 National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration), Beijing,
102629
2 Beijing Institute of Medical Device Testing, Beijing, 101111

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摘要 基于目前计算机辅助诊断软件产品的发展现状,结合国内外的监管现实,并根据当前的《医疗器械分类目录》和相关法 规,对辅助诊断类软件产品的属性界定和管理类别划分进行了探讨和分析,对采用人工智能等新技术的辅助诊断软件类 别划分原则提出了技术建议,供监管和技术部门参考。
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关键词计算机辅助诊断软件   人工智能   医疗器械分类     
Abstract: Based on the developing situation of Computer Aided Diagnosis/Detection (CAD) software, considering the domestic and international regulation of CAD software, according to current Medical Device Classification Catalog and related laws of China Food and Drug Administration (CFDA), this paper investigated and analyzed the classification of CAD software, and provided technical suggestion on classifying principle of CAD software applying Artificial Intelligence (AI) or other advanced technology from medical device regulation scope, for the reference of regulatory and technical departments.
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Received 2018-12-14;
Corresponding Authors: 余新华,编审     Email: yuxinhua@nifdc.org.cn
About author: 戎善奎,高级工程师,E-mail:yasonky@163.com
引用本文:   
戎善奎1,江潇1,冯建2,张春青1,余新华1.计算机辅助诊断软件产品分类管理研究  [J]  中国医疗器械杂志, 2019,V43(5): 359-361
RONG Shankui1, JIANG Xiao1, FENG Jian2, ZHANG Chunqing1, YU Xinhua1.Researching on the Classification of Computer Aided Diagnosis/Detection Software[J]  Chinese Journal of Medical Instrumentation, 2019,V43(5): 359-361
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