Unverified50% confidenceFactExact time
医学AI产品被归类为医疗器械软件（SaMD），这一概念框架由国际医疗器械监管机构论坛（IMDRF）于2013年正式提出
1
Sources
50%
Confidence
Long-term
Relevance
7/14/2026
First Seen
Sources
疟疾细胞AI识别：医学影像分类实践全解析
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