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. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020.
2. IPSOS Patient Satisfaction Study sponsored by GE HealthCare, conducted with 315 patients across 2 sites in Europe, out of which 160 were offered the patient-assisted compression option, February 2017.
3. 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.]
4. Per system. For Pristina 2D & 3D. Data on file. GE HealthCare 2020.
5. 510(k) K211215. Patient motion 74%, skin fold 88%, halo 76% artifacts were reduced according to the 3 readers. Reader study performed by 3 MQSA qualified radiologists on 50 clinical images, comparing SenoBright HD with NIRA to current version.