510(k) Report

Devices descending from K063628

18 later devices reach Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+1K081630Mammo WorkstationImage Diagnost International GmbH20084—
+1K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+2K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+2K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+2K123575MammoworkstationImage Diagnost International GmbH20132—
+2K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+3K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+3K143361Mammo WorkstationGE Healthcare20151—
+3K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+3K120514CardiopacsLumedx20120—
+4K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+4K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+4K160937SenolrisGE Healthcare20160—
+5K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+6K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+7K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+8K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—