# K073138: Cardiq Express Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Feb 26, 2008 after 111 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.
32 later devices descend from it; 6 cite it directly.
0 of 38 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.

## 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 Xpress 2.0 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. CardlQ Xpress 2.0 is a CT, non-invasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardlQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardlQ Xpress 2.0 the user can color code the myocardial tissue to show hypo/hyper-dense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to align the heart. The IVUS-like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added. CardIQ Xpress 2.0 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/K073138
Methodology: https://510kreport.com/methodology