CardIQ Suite
GE Medical Systems SCSCardIQ Suite by GE Medical Systems is a non-invasive software tool designed to analyze 2D and 3D cardiac CT images, helping clinicians visualize and measure cardiovascular anatomy, including vessels and chamber mobility. It uses advanced AI algorithms for automatic calcium scoring and labeling of calcified plaques, aiding in diagnosis and treatment planning of cardiovascular diseases like coronary artery disease. The software also facilitates tracking calcium progression and supports clinicians with integrated workflows for reviewing coronary CT angiography data effectively.
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
Employs AI with a deep learning algorithm to automatically segment and label calcifications in coronary arteries for calcium scoring based on Agatston/Janowitz 130 and Volume scoring methods. Provides manual scoring and interactive 2D coronary review toolset. The software exports results as DICOM SR and supports visualization and measurement tools for clinical workflow.
Performance
The device underwent design control, risk analysis, verification and validation testing under GE's quality system. Clinical testing compared automated calcium scoring against manual expert scores, showing high correlation and equivalent performance to predicate. It passed acceptance criteria on a representative clinical database without safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/26/2021
3 months - 2
FDA Approval
3/11/2022
Other devices from GE Medical Systems SCS
- CardIQ Suite2024 • 510K
- Spine Auto Views2023 • 510K
- FlightPlan for Embolization2023 • 510K
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