# K031261: Card EP

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: May 6, 2003 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 K003408 (2000). 2 ancestors in all.
84 later devices descend from it; 2 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020796: Card IQ Analysis II, GE Medical Systems (2002) Summary page 2.

## Most influential descendants
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own
- K073156: Qplaque MR (2008), 21 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K072821: Vitrea 4DCT (2008), 17 descendants of its own
- K122429: Vessel Analysis and Autoplaque for Ors Visual (2012), 16 descendants of its own

## Indications for use
CardEP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

Source page: https://510kreport.com/device/K031261
Methodology: https://510kreport.com/methodology