Research Advances in Supervision on AI-Based Medical Imaging Products
摘要
Artificial intelligence (AI) medical devices refer to medical devices based on medical device data using artificial intelligence technology to achieve medical use. Medical device software can be divided into AI software as medical devices (AI-SaMD) and AI software in medical devices (AI-SiMD). The former refers to the artificial intelligence software as a medical device, while the latter refers to the artificial intelligence software contained in medical devices.