三维超声成像产品安全性、有效性评价思考

摘要

This article introduces three-dimensional ultrasonography products comprehensively, considers the evaluation of their safety and effectiveness and gives some opinions on technical review. It is hoped to be helpful for three-dimensional ultrasonography products registration and technical review.%该文对三维超声成像产品进行全面的介绍，并对其安全性、有效性的评价进行思考，从技术审评的角度提出看法，以期对三维超声成像产品设备注册及技术审评有所帮助。