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1. GE screening protocol consists of 3D CC/MLO + V-Preview CC/MLO, V-Preview is the 2D synthesized image generated by GE Seno Iris mammography software from GE DBT images. FDA PMA P130020/S001 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P130020S001, Data on file.