# K213972: Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Information Technologies, Inc.
- Decided: Feb 17, 2022 after 59 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: 7 generations back to K001305 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130626: Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic and Electrophys, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 7.

## Most influential descendants
- K243540: Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (2024), 0 descendants of its own

## Recalls of this device
- Aug 8, 2023 · Class II · Z-2613-2023: A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.

## Indications for use
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements, which may then be displayed, filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations. The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements, which may then be displayed filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations. The ComboLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. ComboLab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. The MLCL Client Software is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. MLCL Client Software may be used in a variety of hospital and clinical settings to record, document and/or review hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.

Source page: https://510kreport.com/device/K213972
Methodology: https://510kreport.com/methodology