Vitrea CT Brain Perfusion
Vital Images, Inc.Vitrea CT Brain Perfusion is a software tool that processes CT imaging data to calculate and visualize brain blood flow parameters. It helps physicians assess brain perfusion in patients with acute stroke by highlighting areas with decreased blood flow, supporting clinical decision-making.
Intended Use
Non-invasive post-processing application designed to evaluate areas of brain perfusion by calculating cerebral blood flow, volume, bolus timing, and mean transit time from dynamic CT images after contrast injection.
Technology
Software employs quantitative post-processing of dynamic CT images to generate perfusion maps including CBF, CBV, MTT, and time to peak. Incorporates a Bayesian algorithm for robust, noise-resistant parameter estimation and supports features like motion correction, ROI templating, and mirrored regions, enhancing usability. User can select algorithm type (Bayesian or SVD+).
Performance
Software verification and validation confirmed feature functionality and risk mitigations. Bayesian algorithm was validated through algorithm-specific testing and external physician evaluation showed equivalence in safety and effectiveness to predicate SVD+ algorithm. No separate clinical studies were required. Risk assessment showed all risks to be improbable.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/10/2018
6 months - 2
FDA Approval
11/20/2018
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