FDAnews Device Daily Bulletin

FDA APPROVES ACCREDITATION OF TWO FULL-FIELD DIGITAL MAMMOGRAPHY UNITS

July 7, 2006
A A

On June 29, 2006, the Food and Drug Administration (FDA) approved ACR to accredit GE Senographe Essential FFDM units beginning July 15, 2006. As of that date, all new applicants with this types of GE units must contact the ACR and apply for the accreditation of these units. On June 29, 2006, the FDA approved the STX to accredit Siemens Mammomat Novation DR FFDM units in the State of Texas beginning June 29, 2006. FDA (http://www.fda.gov/cdrh/mammography/digital.html)