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
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=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.]