510(k) Report

Devices descending from K042177

30 later devices reach Modification to Mac 5000 Ecg Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073625Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies20087—
+1K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies200621—
+2K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+2K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+2K103765Mac 600 Resting Ecg Analysis SystemGe Medical Systems Information Technologies, Inc.20110—
+2K110266Mac 5500 HD, Mac 3500Ge Medical Systems Information Technologies, Inc.20111—
+2K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies201019—
+2K093172Quantitative Electrocardiographic Detector (Qed 1000)Dynacardia, Inc.20100—
+2K092663Eli 350 ElectrocardiographMortara Instrument, Inc.200901
+3K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+3K162012CARESCAPE Central Station V2GE Healthcare201676
+3K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc.20160—
+3K14196312SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc.20156—
+3K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc.201491
+3K103791Physioglove ES with Ecg AnalysisCommwell, Ltd.20111—
+4K231010CorvairAliveCor, Inc.20241—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.20182—
+4K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+4K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+4K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc.201611
+4K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+5K252589Corvair MonzaAliveCor, Inc.20260—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K201060Cordiana Dx16Cordiana Medical Informatics AG20200—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401