510(k) Report

Devices descending from P030010

31 later devices reach Siemens Mammomat Novationdr Full Field Digital Mammography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123520Mammomat Inspiration PrimeSiemens Medical Solutions USA, Inc.201371
+1K122286Mammomal InspirationSiemens Medical Solutions USA, Inc.201325
+1K110572Mammodiagnost DRPhilips Medical Systems20110—
+1K111361Planmed Nuance ExcelPlanmeca USA, Inc.20114—
+1K110729Aspire HD Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc.201153
+1K042868Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc.20057—
+2K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.201862
+2K163328Planmed ClarityPlanmed OY20173—
+2K163252Mammomat Fusion with Stereotactic BiopsySiemens Medical Solutions USA, Inc.20170—
+2K151645MAMMOMAT FusionSiemens Medical Solutions USA, Inc.201511
+2K123420Syngo, Breast CareSiemens Medical Solutions USA, Inc.201331
+2K121674Aspire HD Plus, Aspire HD-SFujifilm Medical System U.S.A., Inc.201242
+2K052461Syngo Imaging Version V20ASiemens AG Medical Solutions200523
+3K202822HelianthusMetaltronica Spa20210—
+3K212621MAMMOVISTA B.smartSiemens Medical Solutions USA, Inc.20212—
+3K192317Planmed Clarity 2D and Clarity SPlanmed OY20201—
+3K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc.202041
+3K190809Sample Imaging for Senographe PristinaGE Healthcare20190—
+3K133972Aspire CristalleFujifilm Medical Systems U.S.A, Inc.201432
+3K070796Chili PacsChili GmbH20070—
+3K060210MediportMaxant Technologies, Inc.20060—
+4K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.20241—
+4K223501ViewFinder Software Version 1.1Elaitra, Ltd.20230—
+4K223363MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc.20230—
+4K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY20220—
+4K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+4K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+4K173132ASPIRE CristalleFujifilm Medical Systems U.S.A, Inc.20172—
+5K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.20260—
+5K212873Aspire CristalleFujifilm Corporation20221—
+6K243420HestiaGenoray Co., Ltd.20250—