# K050093: Mac-Lab/Cardiolab EP/Combolab System - Pathway: 510(k) (Traditional) - Applicant: Ge Medical Systems Information Technologies - Decided: May 13, 2005 after 119 days - Product code: DQK (Computer, Diagnostic, Programmable) - Device class: 2 - Regulation: 21 CFR 870.1425 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K001305 (2000). 3 ancestors in all. 15 later devices descend from it; 2 cite it directly. 0 of 19 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K032577: Modification to: Mac-Lab/Cardiolab EP/Combolab System, Ge Medical Systems Information Technologies (2003) Summary page 1. ## Most influential descendants - K061741: Mac-Lab/Cardiolab /Combolab/Specialslab System (2006), 10 descendants of its own - K111200: Mac-Lab System, Cardiolab System, Combolab System, Specialslab System (2011), 8 descendants of its own - K130626: Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic and Electrophys (2013), 7 descendants of its own - K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own - K131497: Mckesson Cardiology Hemo (2013), 3 descendants of its own ## Recalls of this device - Apr 22, 2024 · Class II · Z-2258-2024: Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG wavefo - Feb 16, 2007 · Not classified · Z-1133-2007: GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues - Feb 16, 2007 · Not classified · Z-1134-2007: GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues - Feb 16, 2007 · Not classified · Z-1132-2007: GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues ## Indications for use Mac-Lab System: The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record cardiovascular data from adult and pediatric patients undergoing cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO₂), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemondynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during procedure. The Mac-Lab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities. CardioLab EP System: The CardioLab EP System is intended for use in an electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record electrophysiological data from adult and pediatric patients under going electrophysiological studies. Data includes: ECG, pressure, and intracardiac electrocardiogram (IECG) waveforms, heart rate, pulse oximetry (SpO₂), respiration rate, EtCO2, temperature, invasive and noninvasive blood pressure, and procedural information. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP System? does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab EP System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities. ComboLab System: The ComboLab System is the combination of tie both the Mac-Lab and CardioLab EP systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related speciality laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab Sysiem or the CardioLab EP System, although only one may be used at a time. Source page: https://510kreport.com/device/K050093 Methodology: https://510kreport.com/methodology