ADAS 3D
Galgo Medical S.LADAS 3D is a software application designed to help medical professionals visualize and analyze 3D cardiac images obtained from MRI and CT scans. It supports the quantification and visualization of myocardial scar and other cardiac features to assist clinical decision-making for patients with cardiovascular disease. The software enables detailed analysis of the heart's structure and enhancement patterns, facilitating better cardiovascular disease assessment.
Intended Use
ADAS 3D is indicated for use in clinical settings to support visualization and analysis of cardiac MR and CTA images for patients with cardiovascular disease, specifically myocardial scar produced by ischemic or non-ischemic heart disease.
Technology
ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced MRI and CT angiography images. It processes DICOM image databases for calculation, quantification, and visualization of 3D cardiac imaging data, including enhancement levels and cardiac chamber shapes. It exports data in industry-standard formats compatible with electrophysiology navigation systems.
Performance
ADAS 3D has undergone non-clinical validation with synthetic and phantom data and clinical data testing to establish safety and performance, according to FDA guidance and standards including ISO 14971 and ISO 62304.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/29/2019
8 months - 2
FDA Approval
1/15/2020
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