CardIQ Suite
GE Medical Systems SCSCardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.
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 2D/3D CT cardiac DICOM data, providing automatic and manual measurements, vessel visualization, calcium scoring based on Agatston and volume methods, and heart fat volume estimation. It includes deep learning algorithms for heart segmentation and image processing techniques for vessel lumen measurements.
Performance
The device was tested using retrospective multi-site CT datasets covering various acquisition parameters and pathologies. Heart segmentation showed >90% success on 111 exams. Heart fat volume estimate had an average Dice score ≥90%. Lumen diameter quantification was validated on 94 exams versus predicate device, showing sufficient agreement. Modified algorithms for coronary tracking and labeling demonstrated enhanced performance. No new safety concerns were identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2024
6 months - 2
FDA Approval
6/18/2025
Other devices from GE Medical Systems SCS
- VersaViewer2025 • 510K
- 3DXR2025 • 510K
- CardIQ Suite2024 • 510K
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