510(k) Report

Devices descending from K946281

19 later devices reach Eclipse 4 Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+1K062469Voyager 12Del Mar Reynolds Medical, Ltd.20060—
+1K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.2005131
+1K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.20041—
+1K031970Infinity MegacareSiemens Medical Solutions USA, Inc.200314—
+2K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+2K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc.20070—
+2K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.20068—
+3K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+3K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+3K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.201272
+4K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+4K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+5K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+5K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+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—