510(k) Report

Devices descending from K964784

29 later devices reach Synergy Cardiology Information System (00431) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc.200320—
+1K982384MercatorHarley Street Software, Ltd.19997—
+2K161465CardioConfirmMortara Instrument, Inc.20160—
+2K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.20068—
+2K052883CardioserverDatrix200541
+2K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.2005131
+2K022297Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.20020—
+2K013354GlobalcardioCardiocomm Solutions, Inc.20025—
+3K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+3K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+3K123466Healthview Ecg ManagerLumedx20120—
+3K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.201272
+3K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+3K103427Mobileecg SystemMemtec Corp.20111—
+3K033037Modification to GlobalcardioCardiocomm Solutions, Inc.20034—
+4K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+4K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+4K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+4K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+4K122632Guava IICardiocomm Solutions, Inc.20142—
+5K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+5K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+5K162571Bioflux SoftwareBiotricity, Inc.20161—
+5K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+6K201040Bioflux Software IIBiotricity20200—
+6K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K200822BraidBraid.Health20201—
+8K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—