vascuCAP
Elucid Bioimaging Inc.vascuCAP is a medical image analysis software designed to help clinicians process and evaluate multidimensional CT images of arterial vessels. It provides tools to visualize vessels in 3D and measure key anatomical features such as lumen boundaries, vessel stenosis, and plaque characteristics. This assists physicians in stratifying patients with atherosclerosis by providing detailed vessel information to complement standard care.
Intended Use
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multidimensional digital images acquired with contrast from CT imaging devices. It is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis by providing tools for measurement and visualization of arterial vessels.
Technology
vascuCAP is an image analysis software package that provides multidimensional visualization of CT images of arterial vessels. It post-processes images using refined algorithms to segment and measure lumen boundaries, stenosis, and vessel characteristics including plaque burden and composition, with manual editing capabilities. The software facilitates visualization in 3D and orthogonal views with semi-automatic and manual measurements.
Performance
Software verification and validation were done following FDA guidelines including installation, operation qualification, and system requirement testing. Validation included phantom and clinical image testing comparing measurements of vessel structures and tissue characteristics against ground truth from anthropomorphic phantoms and histopathology specimens. Performance metrics showed high accuracy in lumen area, wall area, stenosis, vessel thickness, and plaque burden measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/31/2018
1 month - 2
FDA Approval
12/21/2018
Other devices from Elucid Bioimaging Inc.
- ElucidVivo A.32022 • 510K
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