510(k) Report

Devices descending from K915225

25 later devices reach Megacart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974698Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment AnalysisSiemens Medical Solutions USA, Inc.19988—
+1K980625Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg)Siemens Medical Solutions USA, Inc.199823—
+2K033305Infinity Multiview Infinity Telemetry SystemDraeger Medical Systems, Inc.20030—
+2K031970Infinity MegacareSiemens Medical Solutions USA, Inc.200314—
+2K030738Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc.20037—
+3K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+3K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.20068—
+3K06030712 RL AlgorithmGe Medical Systems Information Technologies20065—
+3K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.2005131
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+4K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.201272
+5K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+5K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+5K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+6K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+6K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+6K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+7K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K200822BraidBraid.Health20201—
+9K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—