Fed Regist. 1998 Nov 9;63(216 Pt 1):60352.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Approval of an Alternative Requirement of the Mammography Quality Standards Act" (the MQSA). The MQSA final regulations require that the collimation of the mammography unit permit the x-ray field to extend to or beyond the edges of the image receptor. FDA has approved a request from General Electric (GE) Medical Systems for an alternative to the MQSA requirement to apply to GE Senographe mammographic systems.
美国食品药品监督管理局(FDA)宣布可获取一份题为《乳腺X线摄影质量标准法案(MQSA)替代要求的批准》的文件。MQSA最终法规要求乳腺X线摄影设备的准直功能应使X射线野能够延伸至图像接收器的边缘或超出其边缘。FDA已批准通用电气(GE)医疗系统公司提出的一项请求,即对适用于GE Senographe乳腺X线摄影系统的MQSA要求采用替代方案。