# K061370: Cardiq Fusion

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: May 30, 2006 after 13 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: 5 generations back to K954874 (1996). 20 ancestors in all.
51 later devices descend from it; 4 cite it directly.
0 of 72 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.
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001) Summary page 1.
- K013422: Cardiq Function, GE Medical Systems (2001) Summary page 1.
- K040141: Emory Cardiac Toolbox Version 2.6, Syntermed, Inc. (2004) Summary page 1.
- K060779: Advance Vessel Analysis II, GE Healthcare (2006) Summary page 1.

## Most influential descendants
- K103465: Synapse 3D Cardiac Tools (2011), 20 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool (2009), 19 descendants of its own
- K122429: Vessel Analysis and Autoplaque for Ors Visual (2012), 16 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own

## Indications for use
CardlQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data. CardlQ Fusion isa software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information. With CardlQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardlQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque). Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner, or they could come from separate scanners like stand alone NUC camera and stand alone CT scanner.

Source page: https://510kreport.com/device/K061370
Methodology: https://510kreport.com/methodology