Radiation-Emitting Products

Which FFDM units have been approved by FDA?

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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)

 

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Page Last Updated: 08/13/2014
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