510(k) Report

Devices descending from K001305

31 later devices reach Mac-Lab System and Cardiolab EP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021366Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn2002301
+2K032577Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies200329—
+3K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division201212—
+3K050093Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies2005154
+4K140497Ecvue Mapping SystemCardioinsight Technologies, Inc.20148—
+4K141185V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp20142—
+4K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+4K061741Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare200610—
+5K230008Ablamap® SystemAblacon, Inc.20231—
+5K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+5K150990ECVUE Mapping SystemCardioinsight Technologies, Inc.20157—
+5K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+5K111200Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare20118—
+5K082421Heartsuite Hemodynamics 7.10Emageon, Inc.2008211
+6K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+6K251344OptiMap™ SystemBoston Scientific Corporation20250—
+6K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+6K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+6K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.20166—
+6K152864Merge HemoMerge Healthcare Incorporated201612
+6K130626Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Ge Medical Systems Information Technologies, Inc.201371
+7K253861Acorys Mapping SystemCorify Care S.L20260—
+7K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated202401
+7K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording…Ge Healthcare Information Technologies, Inc.202211
+7K183195VIVOCatheter Precision, Inc.20191—
+7K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc.20182—
+7K180805Pure EPBiosig Technologies20180—
+8K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…Ge Medical Systems Information Technologies, Inc.20240—
+8K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+8K200313VIVOCatheter Precision, Inc.20200—
+9K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—