# K021366: Mac-Lab/Cardiolab EP/Combolab

- Pathway: 510(k) (Special)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Jul 3, 2002 after 64 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001305 (2000). 1 ancestor in all.
30 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001305: Mac-Lab System and Cardiolab EP System, General Electric Medical Systems Information Techn (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K912829: Cardiotrace Cardiac Evaluation Systems, Cine Graphics, Inc. (1991). Our reading of the summary gave K912829, FDA’s number for Cardiotrace Cardiac Evaluation Systems (Cine Graphics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CardioTreeBCoronary Tree Diagrams”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K032577: Modification to: Mac-Lab/Cardiolab EP/Combolab System (2003), 29 descendants of its own
- K050093: Mac-Lab/Cardiolab EP/Combolab System (2005), 15 descendants of its own
- K113811: V2.6 Software for the Labsystem Pro EP Recording System (2012), 12 descendants of its own
- K061741: Mac-Lab/Cardiolab /Combolab/Specialslab System (2006), 10 descendants of its own
- K140497: Ecvue Mapping System (2014), 8 descendants of its own

## Recalls of this device
- Apr 14, 2003 · Not classified · Z-0783-03: There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.

## Indications for use
MAC-LAB System: The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Medical Systems Information Technologies TRAM modules (k921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO*), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The 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 under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. 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, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. The ComboLab System The ComboLab is the combination of both CardioLab EP and ‘MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. The MAC-LAB / CardioLab EP and Combotab systems do not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure. Applicable to pediatridadult patients requiring cardiac/circulatory system catheterization. Intended for use in catheterization and related cardiovascular specialty labs

Source page: https://510kreport.com/device/K021366
Methodology: https://510kreport.com/methodology