X射线高频高压发生器产品技术审评概要研究

Research on X-Ray High-Frequency High-Voltage Generator Product Technical Review Summary

X射线高频高压发生器装配于诊断X射线机,为X射线管组件提供电能,以发出X射线。X射线高频高压发生器为诊断X射线机的核心部件,文章针对该产品申报注册中常见问题,进行归纳和分析,为医疗器械注册相关人员提供技术参考。

The X-Ray high-frequency high-voltage generator is equipped with a diagnostic X-Ray machine to provide electrical energy to the X-Ray tube assembly to emit X-rays.Among them,the X-Ray high-frequency high-voltage generator is the core component of the diagnostic X-Ray machine.It summarizes and analyzes the common problems in the application for registration of the product,and provides technical reference for medical device registration related personnel.