510(k) Report

Devices descending from K040125

18 later devices reach Senographic Stereo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173576Pristina SerenaGE Healthcare201823
+1K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic201601
+1K071542Digital Stereoloc IILorad, A Hologic Co.200714—
+2K193334Pristina Serena BrightGE Healthcare202001
+2K182951Pristina Serena 3DGE Healthcare201902
+2K103512Affirm Breast Biopsy Guidance SystemHologic, Inc.201113—
+3K202294Affirm Contrast BiopsyHologic, Inc.20200—
+3K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co.20139—
+3K113284Biopsy PositionerFuji Film Medical Systems201211
+4K191495Biopsy PositionerFujifilm Corporation20190—
+4K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+4K153486Affirm Prone Biopsy SystemHologic, Inc.20160—
+5K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.202041
+5K190809Sample Imaging for Senographe PristinaGE Healthcare20190—
+6K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.20241—
+6K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+6K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+7K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.20260—