CardIQ Suite
GE Medical Systems SCSCardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.
Intended Use
CardIQ Suite is a collection of non-invasive software features intended to analyze CT cardiovascular anatomy and pathology and aid in determining treatment paths.
Technology
CardIQ Suite works with DICOM CT data of the heart, uses automated segmentation and labeling via deep learning algorithms for coronary and heart structures, calcium scoring using Agatston and volume methods, and provides visualization and measurement tools for vessels and chamber mobility within a seamless workflow.
Performance
The device underwent design control testing, bench testing on retrospectively acquired CT data for deep learning algorithms, and a reader clinical evaluation that showed over 90% acceptance for automated heart and coronary segmentation, tracking and labeling, demonstrating improved workflow efficiency without safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2023
8 months - 2
FDA Approval
8/1/2024
Other devices from GE Medical Systems SCS
- Spine Auto Views2023 • 510K
- FlightPlan for Embolization2023 • 510K
- CardIQ Suite2022 • 510K
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