510(k) Report

Devices descending from P990066

23 later devices reach GE Healthcare Senographe Full Field Digital Mammography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151645MAMMOMAT FusionSiemens Medical Solutions USA, Inc.201511
+1K131885Senographe Essential, Premium View I (Pvi)GE Medical Systems SCS20130—
+1K110798Senographe DS, Senographe EssentialGeneral Electric Company20113—
+1K111434Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC20110—
+1K103485Senograph DS, Senograph EssenstialGeneral Electric Company201111—
+1K110025Sectra Microdose MammographySectra Imtec AB20113—
+2K220073RMF-2000DRTECH Corporation20231—
+2K172404SenoBright HDGE Healthcare20171—
+2K163252Mammomat Fusion with Stereotactic BiopsySiemens Medical Solutions USA, Inc.20170—
+2K123995Microdose SIPhilips Digital Mammography Sweden AB20131—
+2K123873Contrast Enhanced Digital MammographyHologic, Inc.201381
+2K120255Philips MicrodosePhilips Digital Mammography Sweden AB20122—
+3K254090I-View®Hologic, Inc.20260—
+3K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.20260—
+3K211215SenoBright HDGE Healthcare202101
+3K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+3K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+4K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.202041
+4K190809Sample Imaging for Senographe PristinaGE Healthcare20190—
+5K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.20241—
+5K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+5K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+6K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.20260—