Abstract: Artificial intelligence, as the breakthrough of current information technology, is gaining importance and being applied in more and more industries. Research on the application of artificial intelligence to the medical field has gradually matured and some products have come out. Relevant products in the United States have been approved by the FDA, mainly for image-based software products. In this paper, we studied the cases of image-based artificial intelligence aided diagnosis software approved by the US FDA, and analyzed the listing routes, clinical evaluation methods and clinical data processing of representative artificial intelligence products, and summarized the clinical evaluation characteristics of FDA for image-based artificial intelligence aided diagnosis software. Finally, problems that may be encountered in the clinical evaluation of similar products in China were considered, and relevant suggestions were put forward.