Viz LVO ContaCT
Viz.ai, Inc.Viz LVO is an AI-based software tool designed for hospital networks and clinicians to detect and notify specialists about suspected large vessel occlusions in brain CT angiograms. It facilitates rapid communication and prioritization of cases to improve stroke patient management, providing image previews via a mobile app for informational use to assist timely specialist review.
Intended Use
Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. It analyzes CT angiogram images of the brain acquired in the acute setting to notify a neurovascular specialist of suspected large vessel occlusion.
Technology
Uses an AI machine learning algorithm hosted on a backend server to analyze stroke-protocol CT angiography images of the head for suspected large vessel occlusion. The device includes a mobile notification software module integrated into a non-diagnostic DICOM viewer app that allows users to receive notifications and view non-diagnostic compressed image previews.
Performance
No new clinical performance data was included for this modification. Software verification and validation testing were performed to demonstrate the implementation of device changes without affecting safety or effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2022
22 days - 2
FDA Approval
10/21/2022
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