Viz AAA
Viz. ai, Inc.Viz AAA is an AI-powered software device designed to analyze CT angiogram images of the abdomen to detect suspected abdominal aortic aneurysms. It helps specialists prioritize patient studies by flagging those with potential aneurysms, improving workflow efficiency in clinical settings. The software provides non-diagnostic preview images and emphasizes that diagnostic decisions remain with treating specialists.
Intended Use
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular or endovascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care.
Technology
Viz AAA uses an AI/ML software algorithm to analyze CTA images for abdominal aortic aneurysms. It consists of an image analysis module and a mobile application module (Viz VIEW) that highlights suspected aneurysm cases for prioritization. The device generates compressed preview images for informational purposes and does not alter original images.
Performance
Performance testing involved 466 CTA scans from two U.S. clinical sites. The device showed 96% sensitivity and 95% specificity for detecting abdominal aortic aneurysms, with an AUC of 0.99, exceeding performance goals. Stratified analyses by age, sex, CT scanner type, aneurysm size, and imaging protocol supported consistent high performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2022
4 months - 2
FDA Approval
3/17/2023
Other devices from Viz. ai, Inc.
- Viz HDS, Viz Volume Plus, Viz ICH+2024 • 510K
- Viz HCM2023 • DE NOVO
- Viz LVO ContaCT2022 • 510K
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