Approval of an alternative requirement of the Mammography Quality Standards Act; availability--FDA. Notice.
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.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D005260:Female; D006801:Humans; D008327:Mammography / Q000295:instrumentation / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D011835:Radiation Protection / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration