510(k) Report

Devices descending from K030666

16 later devices reach Multicare Platinum System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153486Affirm Prone Biopsy SystemHologic, Inc.20160—
+1K040884Lorad Digital Spot Mammography SystemHologic, Inc.200415—
+2K071542Digital Stereoloc IILorad, A Hologic Co.200714—
+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
+5K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic201601
+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—