# K013422: Cardiq Function

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 30, 2001 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000315 (2000). 1 ancestor in all.
449 later devices descend from it; 6 cite it directly.
1 of 451 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000315: Ventricular Analysis Toolkit Option, GE Medical Systems (2000) Summary page 1.

## Most influential descendants
- K041267: Cardiq Analysis Iii (2004), 331 descendants of its own
- K052029: Syngo Circulation (2005), 296 descendants of its own
- K063762: Syngo Circulation Software Package with Extended Functionality (2007), 263 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K023760: CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B (2002), 174 descendants of its own

## Indications for use
The CardlQ Function is a software package that can be used in conjunction with CT Cardiac images to (semi-automatically) calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic Volumes, Stroke Volume, LV Ejection Fraction including Peak Filling and Ejection Rates, Myocardial Mass Calculations, Regional Wall Motion Display and Analysis. When interpreted by a trained physician, the software aids in assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.

Source page: https://510kreport.com/device/K013422
Methodology: https://510kreport.com/methodology