# K073153: Cardiq Function Xpress

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Feb 26, 2008 after 110 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: 3 generations back to K000315 (2000). 5 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041267: Cardiq Analysis Iii, General Electric Medical Systems (2004) Summary page 1.
- K013422: Cardiq Function, GE Medical Systems (2001) Summary page 1.

## Most influential descendants
- K110366: Syngo.CT Cardiac Function (2011), 25 descendants of its own
- K123585: Syngo, CT Cardiac Function (2012), 14 descendants of its own
- K183268: AI-Rad Companion (Cardiovascular) (2019), 11 descendants of its own
- K210085: HealthCCSng (2021), 9 descendants of its own
- K230223: iCAC Device (2023), 6 descendants of its own

## Indications for use
CardIQ Function Xpress is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic Images. CardIQ Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management. CardIQ Function Xpress is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.

Source page: https://510kreport.com/device/K073153
Methodology: https://510kreport.com/methodology