510(k) Report

Devices descending from K050093

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+1K061741Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare200610—
+2K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+2K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+2K111200Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare20118—
+2K082421Heartsuite Hemodynamics 7.10Emageon, Inc.2008211
+3K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+3K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+3K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+3K152864Merge HemoMerge Healthcare Incorporated201612
+3K130626Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Ge Medical Systems Information Technologies, Inc.201371
+4K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated202401
+4K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording…Ge Healthcare Information Technologies, Inc.202211
+4K180805Pure EPBiosig Technologies20180—
+5K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…Ge Medical Systems Information Technologies, Inc.20240—