# K213725: CardIQ Suite

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Mar 11, 2022 after 105 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: 4 generations back to K945512 (1995). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5, GE Medical Systems (2002) Summary page 5.

## Most influential descendants
- K233731: CardIQ Suite (2024), 2 descendants of its own
- K243672: CardIQ Suite (2025), 1 descendant of its own
- K253770: CardIQ Suite (2026), 0 descendants of its own
- K252217: CT VScore+ (2025), 0 descendants of its own

## Indications for use
CardlQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardlQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardlQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. Calcium Scoring may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

Source page: https://510kreport.com/device/K213725
Methodology: https://510kreport.com/methodology