GE Healthcare Mammography
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1. Superior diagnostic accuracy demonstrated in a reader study comparing the ROC AUC of GE screening protocol (V-Preview + 3D CC/MLO with 3D in STD mode) to that of 2D FFDM alone. V-Preview is the 2D synthesized image generated by GE Seno Iris mammography software from GE DBT images. FDA PMA P130020
Comparison of patient dose delivered by FDA approved DBT devices as of February 2018 for a breast of average density, based on data presented in [1-2] and data on file. Device comparison includes GE SenoClaire, GE Senographe Pristina 3D in STD mode, Hologic Selenia Dimensions, Siemens Mammomat Inspiration, Fuji Aspire Cristalle [1. Bouwman, R. W. and al., et. 2015, Physics in Medicine & Biology, pp. 7893-7907; 2. NHSBSP Equipment Reports 1306, 1404, 1307, and on Fujifilm AMULET Innovality.]