# K162023: CardioDay V2.5

- Pathway: 510(k) (Traditional)
- Applicant: Getemed Medizin- Und Informationstechnik AG
- Decided: Mar 24, 2017 after 245 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: 7 generations back to K930806 (1994). 15 ancestors in all.
1 later device descends 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)
- K130516: Cardioday, Getemed Medizin- Und Informationstechnik AG (2013) Summary page 4.
- K132437: Mars Holter Analysis Workstation, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 4.

## Most influential descendants
- K242583: AT-Patch (ATP-C130/ATP-C70) (2025), 0 descendants of its own

## Indications for use
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter 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 CardioDay V2.5 system 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 human patients. CardioDay V2.5 provides the user arrhythmia study and Holter analysis capabilities. Data acquired may be used 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/K162023
Methodology: https://510kreport.com/methodology