# K041267: Cardiq Analysis Iii

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems
- Decided: May 27, 2004 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: 2 generations back to K000315 (2000). 4 ancestors in all.
331 later devices descend from it; 7 cite it directly.
1 of 336 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020796: Card IQ Analysis II, GE Medical Systems (2002) Summary page 1.
- K013422: Cardiq Function, GE Medical Systems (2001) Summary page 1.

## Most influential descendants
- 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
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own

## Indications for use
CardlQ Analysis HI is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician for to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardlQ Analysis HI will run on the AW workstation, scanner operator console and PACS system.

Source page: https://510kreport.com/device/K041267
Methodology: https://510kreport.com/methodology