Viz HDS, Viz Volume Plus, Viz ICH+
Viz.ai, Inc.Viz HDS by Viz.ai is an AI-powered software that automatically labels, visualizes, and measures critical brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift on non-contrast head CT scans. This automation helps radiologists quickly and accurately assess brain abnormalities by providing detailed volumetric data and annotated images, improving workflow and diagnostic efficiency.
Intended Use
Automatic labeling, visualization, and quantification of segmentable brain structures from non-contrast head CT scans to aid physicians in assessing intracranial hyperdensities, lateral ventricles, and midline shift.
Technology
Software-only device using a locked AI machine learning algorithm to process non-contrast head CT scans, producing DICOM outputs with segmentation overlays and volumetric measurements of intracranial hyperdensities, lateral ventricles, and midline shift. Hosted on a cloud server, outputs are sent to PACS for physician review.
Performance
Clinical testing compared algorithm outputs to radiologist ground truth, showing mean absolute errors below set thresholds (7.5 mL for hyperdensity volume, 3 mL for ventricular volumes, 2 mm for midline shift). Dice scores for segmentation of hyperdensities and ventricles exceeded 70%, demonstrating high agreement. Performance was consistent across clinical sites and imaging parameters.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/7/2023
6 months - 2
FDA Approval
2/5/2024
Other devices from Viz.ai, Inc.
- Viz HCM2023 • DE NOVO
- Viz AAA2023 • 510K
- Viz LVO ContaCT2022 • 510K
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