510(k) Report

Devices descending from K061905

8 later devices reach Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.201272
+2K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+3K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+3K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+4K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K200822BraidBraid.Health20201—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—