510(k) Report

Devices descending from K021366

30 later devices reach Mac-Lab/Cardiolab EP/Combolab through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032577Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies200329—
+2K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division201212—
+2K050093Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies2005154
+3K140497Ecvue Mapping SystemCardioinsight Technologies, Inc.20148—
+3K141185V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp20142—
+3K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+3K061741Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare200610—
+4K230008Ablamap® SystemAblacon, Inc.20231—
+4K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+4K150990ECVUE Mapping SystemCardioinsight Technologies, Inc.20157—
+4K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+4K111200Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare20118—
+4K082421Heartsuite Hemodynamics 7.10Emageon, Inc.2008211
+5K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+5K251344OptiMap™ SystemBoston Scientific Corporation20250—
+5K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+5K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+5K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.20166—
+5K152864Merge HemoMerge Healthcare Incorporated201612
+5K130626Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Ge Medical Systems Information Technologies, Inc.201371
+6K253861Acorys Mapping SystemCorify Care S.L20260—
+6K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated202401
+6K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording…Ge Healthcare Information Technologies, Inc.202211
+6K183195VIVOCatheter Precision, Inc.20191—
+6K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc.20182—
+6K180805Pure EPBiosig Technologies20180—
+7K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…Ge Medical Systems Information Technologies, Inc.20240—
+7K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+7K200313VIVOCatheter Precision, Inc.20200—
+8K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—