医用诊断X射线设备技术资料审评要点探讨

Discussion on Review Points of Medical Diagnostic X-ray Equipment’s Technical Report

本文旨在通过对医用诊断X射线的特性、成像原理以及医用诊断X射线设备结构和对应的技术资料要求进行分析描述,促进审评人员对医用诊断X射线设备的了解,并有利于各地方政府对此类产品审评尺度的统一。

By analysis of Medical Diagnostic X-ray characteristics,imaging mechanism and Medical Diagnostic X-ray Equipment structure of the composition and the corresponding technical report requirements,the article aims for evaluation staff understanding of Medical Diagnostic X-ray Equipment and to help local governments scale review of such products.