510(k) Report

Devices descending from K941191

20 later devices reach Real Time Stereotix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040125Senographic StereoGe Medical Systems, Inc.200418—
+1K023864Performa StereoInstrumentarium Corp. Imaging Division20030—
+2K173576Pristina SerenaGE Healthcare201823
+2K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic201601
+2K071542Digital Stereoloc IILorad, A Hologic Co.200714—
+3K193334Pristina Serena BrightGE Healthcare202001
+3K182951Pristina Serena 3DGE Healthcare201902
+3K103512Affirm Breast Biopsy Guidance SystemHologic, Inc.201113—
+4K202294Affirm Contrast BiopsyHologic, Inc.20200—
+4K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co.20139—
+4K113284Biopsy PositionerFuji Film Medical Systems201211
+5K191495Biopsy PositionerFujifilm Corporation20190—
+5K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+5K153486Affirm Prone Biopsy SystemHologic, Inc.20160—
+6K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.202041
+6K190809Sample Imaging for Senographe PristinaGE Healthcare20190—
+7K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.20241—
+7K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+7K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+8K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.20260—