FDA Approves the ACR to Accredit General Electric Senographe Essential Full-Field Digital Mammography Units - 6/30/2006
The Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit General Electric Senographe Essential full-field digital mammography (FFDM) units beginning July 15, 2006. As of July 15, all facilities installing General Electric Senographe Essential units must contact the ACR to apply for the accreditation.
Applicants with FFDM units other than the GE Senographe 2000D, GE Senographe DS, GE Senographe Essential, Fischer SenoScan, Lorad Selenia, and Siemens Mammomat Novation DR must apply to and be approved by the FDA for extension of their certificates to include the use of an FFDM unit, in order to operate those units legally.
For more information, please contact the ACR at (800) 227-6440.
