510(k) Report

Devices descending from K031561

30 later devices reach Cardiosoft/Case Cardiac Testing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103678Case Cardiac Testing System, CS Cardiac Testing SystemGe Medical Systems Information Technologies GmbH20111—
+1K102854PC ECGEdan Instruments, Inc.201013—
+1K093211Carecenter MDCardiac Science Corporation20101—
+1K092010PC Ecg, Model SE-1010Edan Instruments, Inc.200918—
+1K091594Heart-ExerciseGe Medical Systems Information Technologies GmbH20090—
+1K081437Mac 1600 Ecg Analysis SystemGe Medical Systems Information Technologies20085—
+2K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemGe Medical Systems Information Technologies, Inc.202301
+2K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—
+2K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+2K131503SE-601 Series ElectrocardiographEdan Instruments, Inc.20149—
+2K131819PC ECGEdan Instruments, Inc.201312—
+2K123217CardeascreenCardea Associates, Inc.20130—
+2K093869SE-601 Series ElectrocardiographEdan Instruments, Inc.201010—
+2K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies200941
+3K160876PC ECGEdan Instruments, Inc.20178—
+3K152427PC ECGEdan Instruments, Inc.201611—
+3K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+3K140020Hyperq Acs-100 SystemBsp-Biiological Signal Processing, Ltd.20140—
+3K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+4K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+4K171942ElectrocardiographEdan Instruments, Inc.20183—
+4K170995ElectrocardiographEdan Instruments, Inc.20173—
+4K161302PC ECGEdan Instruments, Inc.20161—
+5K212278ElectrocardiographEdan Instruments, Inc.20222—
+5K220362LE-12CHCaf Medical Solutions, Inc.20220—
+5K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+5K191692KardioScreenImedrix Inc. (Formerly Piitech Inc.)20200—
+6K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+6K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+7K232210X-trodes System MX-Trodes20240—