510(k) Report

Devices descending from K113515

7 later devices reach Horizon Cardiology Ecg Management through their predicates, nearest generation first.

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