Researching on the Classification of Computer Aided Diagnosis/Detection Software.
10.3969/j.issn.1671-7104.2019.05.013
- Author:
Shankui RONG
1
;
Xiao JIANG
1
;
Jian FENG
2
;
Chunqing ZHANG
1
;
Xinhua YU
1
Author Information
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.
- Publication Type:Journal Article
- Keywords:
artificial intelligence;
classification of medical device;
computer aided diagnosis/detection software
- MeSH:
Artificial Intelligence;
China;
Diagnosis, Computer-Assisted;
Radiographic Image Interpretation, Computer-Assisted;
Software
- From:
Chinese Journal of Medical Instrumentation
2019;43(5):359-361
- CountryChina
- Language:Chinese
-
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.
