510(k) Report

Devices descending from K122836

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+1K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic201601
+1K153486Affirm Prone Biopsy SystemHologic, Inc.20160—
+2K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.202041
+2K190809Sample Imaging for Senographe PristinaGE Healthcare20190—
+3K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.20241—
+3K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+3K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+4K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.20260—