Approval of an Alternative Requirement of the Mammography Quality Standards Act; Availability

概要

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.