# K051026: Mars Holter Analysis Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jul 19, 2005 after 88 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930806 (1994). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option, General Electric Medical Systems Information Techn (1999) Summary page 1.
- K010949: 2010 Plus Holter for Windows, Agilent Technologies (2001) Summary page 1.

## Most influential descendants
- K093141: Mars Holter Analysis Workstation (2009), 7 descendants of its own
- K132437: Mars Holter Analysis Workstation (2013), 6 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K162023: CardioDay V2.5 (2017), 1 descendant of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own

## Indications for use
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities. Data acquired may be use for the following indications: - Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances - Evaluation of symptoms that may be due to myocardial ischemia - Detection of ECG events that alter prognosis in certain forms of heart disease - Detection and analysis of pacemaker function and failure Determination of cardiac response to lifestyle - Evaluation of therapeutic interventions - Investigations in epidemiology and clinical trials

Source page: https://510kreport.com/device/K051026
Methodology: https://510kreport.com/methodology