510(k) Report

Devices descending from K031970

14 later devices reach Infinity Megacare through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.20068—
+1K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.2005131
+2K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+2K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.201272
+3K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+3K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+3K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+4K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+4K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+4K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+5K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K200822BraidBraid.Health20201—
+7K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—