Viz CTP
Viz.ai, Inc.Viz CTP is a software package that processes and analyzes CT perfusion scans of the brain to calculate parameters related to tissue blood flow and volume. It helps clinicians by providing detailed brain perfusion maps that assist in diagnosing and managing neurological conditions, improving clinical decision-making.
Intended Use
Viz CTP is an image processing software package used by trained professionals to perform image processing, analysis, and communication of CT perfusion scans of the brain. It processes dynamic imaging datasets to calculate perfusion-related parameters and outputs them in DICOM format for viewing in radiological systems.
Technology
The device is a standalone software that includes DICOM receiving/sending, study processing, image analysis algorithms, and system health-monitoring modules. It automatically receives, extracts, and analyzes CT brain perfusion DICOM data to generate parametric maps for perfusion and blood volume, and exports results in DICOM format.
Performance
Performance testing included software verification, validation, and comparison using a simulated dataset with known ground truth perfusion parameters. The device met pre-established performance goals for arterial input function detection, soft tissue extraction, and perfusion parameters, demonstrating accuracy comparable to other commercial and academic software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/19/2018
3 months - 2
FDA Approval
4/20/2018
Other devices from Viz.ai, Inc.
- Viz HDS, Viz Volume Plus, Viz ICH+2024 • 510K
- Viz HCM2023 • DE NOVO
- Viz AAA2023 • 510K
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