静态/准静态超声弹性成像产品的安全性、有效性评价思考

摘要

本文对静态/准静态超声弹性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，以期对该产品注册申报及技术审评有所帮助。%This article introduces static/quasi-static elastosonography products comprehensively, considers the evaluation of their safety and effectiveness and gives some opinions on technical review. It is hoped to be helpful for static/quasi-static elastosonography products registration and technical review.