Which FFDM units have been approved by FDA?

FDA’s Office of Device Evaluation has approved the following FFDM units for commercial use:

• GE Senographe 2000D (approval date: 1/28/00)
• Fischer Imaging SenoScan (approval date: 9/25/01)
• Lorad Digital Breast Imager (approval date: 3/15/02)
• Hologic/Lorad Selenia FFDM System (approval date: 10/02/02)
• GE Senographe DS (approval date: 02/19/04)
• Siemens Mammomat Novation DR (approval date: 08/20/04)
• GE Senographe Essentials (approval date: 04/11/2006)
• Fuji Computed Radiography Mammography Suite (FCRm) (approval date: 07/10/06)
• Hologic Selenia Full Field Digital Mammography (FFDM) System with a Tungsten target (approval date: 11/2007)
• Siemens Mammomat Novation S Full Field Digital Mammography (FFDM) System (approval date:  2/11/09)
• Hologic Selenia S Full Field Digital Mammography (FFDM) System (approval date: 2/11/09)
• Hologic Selenia Dimensions 2D Full Field Digital Mammography (FFDM) System (approval date: 2/11/09)
• Carestream Directview Computed Radiography (CR) Mammography System (approval date: 11/3/10)
• Siemens Mammomat Inspiration Full Field Digital Mammography (FFDM) System (approval date: 2/11/11)
• Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System (approval date: 2/11/11)

Back to Full Field Digital Mammography (FFDM) Certification Extension Program