icobrain-ctp
Icometrix NVicobrain-ctp is a software package designed to analyze CT perfusion scans of the brain. It processes imaging data to calculate brain tissue perfusion parameters and volumes affected by abnormalities, providing detailed reports to aid clinicians in stroke and brain blood flow assessment. The tool supports image export in DICOM format and integrates with standard radiological viewing platforms, helping healthcare professionals make informed decisions efficiently.
Intended Use
icobrain ctp is an image processing software package to be used by trained professionals to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. It analyzes parameters related to tissue flow (perfusion) and blood volume and exports CT perfusion parameter maps in DICOM format for viewing.
Technology
Processes DICOM format CT perfusion scans by extracting image data and DICOM tags, calculating perfusion parameters and abnormality volumes (Tmax and CBF). Generates perfusion parameter maps and summaries in standardized electronic reports. Operates on standard computers or virtual platforms like VMware.
Performance
Performance testing included validation on digital simulation phantoms and clinical CT perfusion datasets from stroke patients. Accuracy and reproducibility were assessed by comparing output volumes to ground truth and reference devices. All performance measures met acceptance criteria, with correlations above 0.90, demonstrating device effectiveness and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/22/2019
4 months - 2
FDA Approval
2/28/2020
Other devices from Icometrix NV
- icobrain aria2024 • 510K
- Icobrain2019 • 510K
- icobrain2018 • 510K
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