510(k) Report

Devices descending from K103485

11 later devices reach Senograph DS, Senograph Essenstial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172404SenoBright HDGE Healthcare20171—
+1K123873Contrast Enhanced Digital MammographyHologic, Inc.201381
+2K254090I-View®Hologic, Inc.20260—
+2K211215SenoBright HDGE Healthcare202101
+2K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+3K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.202041
+3K190809Sample Imaging for Senographe PristinaGE Healthcare20190—
+4K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.20241—
+4K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+4K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+5K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.20260—