510(k) Report

Devices descending from K103512

13 later devices reach Affirm Breast Biopsy Guidance System through their predicates, nearest generation first.

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