数字化医用X射线机图像质量评价方法比较研究

为完善我国现有的医用数字X射线摄影系统图像质量评价方法，本文对比研究了美国食品药品监督管理局（下称FDA）的《固体X射线成像设备510（k）提交指南》，和我国食品药品监督管理局（下称SFDA）的《数字化医用X射线摄影系统摄影质量要求及测试方法》，结合SFDA的审评体系及我国国情现状，对医用数字X射线摄影系统图像质量评价方法的发展提出了建议。

Comparative Study on Image Quality Evaluation Method of Medical Digital Radiography System

To perfect the existing image quality evaluation method of medical digital radiography system in China, a comparison is performed between ＂Guidance for the Submission of 510（k）＇s for Solid State X-ray Imaging Devices＂ from Food and Drug Administration （FDA） and ＂Image Quality Requirement and Test Method of Digital Medical X Ray Radiography System＂ from State Food and Drug Administration （SFDA） considered the evaluation mechanism of SFDA and the situation of China in this paper, by which, the recommendation for developing the image quality evaluation method of medical digital X ray radiography system is given.