ElucidVivo A.3
Elucid Bioimaging Inc.ElucidVivo A.3 is a medical image analysis software that processes and visualizes CT angiographic images to help physicians assess arterial vessels and stratify patients with atherosclerosis. It offers tools for measurement and visualization of vessel structure and plaque characteristics, supporting clinical decision-making without providing direct diagnosis.
Intended Use
ElucidVivo is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices, intended to assist trained physicians in the stratification of patients identified to have atherosclerosis.
Technology
ElucidVivo processes multi-dimensional CT images of arterial vessels, providing 3D visualization, rotatable curved MPR views, cross-sectional measurements, and semi-automatic lumen boundary determinations. It uses kVp calibration and MOVAT stain to improve measurement of plaque components.
Performance
The device underwent software verification and validation following FDA guidance including installation, operation, and performance testing with phantom and clinical images. Metrics include bias, slope, RMSE, and wSD for vessel structural and plaque composition measurements, demonstrating safety and effectiveness comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/19/2022
29 days - 2
FDA Approval
6/17/2022
Other devices from Elucid Bioimaging Inc.
- vascuCAP2018 • 510K
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