Viz RV/LV
Viz.ai, Inc.Viz RV/LV is a software tool that uses artificial intelligence to automatically measure the size of the right and left ventricles of the heart from CT pulmonary angiogram scans. It provides annotated images and a summary report to assist clinicians in evaluating right ventricular enlargement, potentially aiding diagnosis and treatment decisions.
Intended Use
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements; provides annotated images for clinical review, but results are not intended for standalone clinical decision-making.
Technology
Software-only device using a locked AI/ML algorithm to measure ventricular diameters from CT scans; produces DICOM annotated image series with color overlays indicating ventricular diameters and interventricular septum; hosted on backend server analyzing DICOM images forwarded from CT scanners and exports results to PACS for clinical review.
Performance
Clinical performance testing demonstrated high agreement of AI measurements with ground truth obtained from trained radiologists; mean absolute error was under 7.2 mm, meeting performance goals; performance was consistent across clinical sites, genders, ages, slice thicknesses, and scanner models.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/14/2022
4 months - 2
FDA Approval
8/29/2022
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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