510(k) Report

Devices descending from K071542

14 later devices reach Digital Stereoloc II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103512Affirm Breast Biopsy Guidance SystemHologic, Inc.201113—
+2K202294Affirm Contrast BiopsyHologic, Inc.20200—
+2K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co.20139—
+2K113284Biopsy PositionerFuji Film Medical Systems201211
+3K191495Biopsy PositionerFujifilm Corporation20190—
+3K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+3K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic201601
+3K153486Affirm Prone Biopsy SystemHologic, Inc.20160—
+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—