# K020796: Card IQ Analysis II

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Mar 26, 2002 after 14 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 K003408 (2000). 1 ancestor in all.
377 later devices descend from it; 4 cite it directly.
1 of 379 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003408: CT Cord IQ Option 1.0, 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
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own

## Indications for use
CardIQ Analysis I is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.

Source page: https://510kreport.com/device/K020796
Methodology: https://510kreport.com/methodology