Viz ICH

Viz.ai, Inc.

510k3/23/2021

FDA #

K210209

Product Code

QAS

Panel

Radiology

Modality:CT Task:Detection Body Region:Neurological Target Condition:Intracranial Hemorrhage

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

Intended Use

Viz ICH 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 non-contrast CT images of the brain acquired in the acute setting to suggest findings of intracranial hemorrhage and notifies a neurovascular or neurosurgical specialist for image review.

Technology

Viz ICH consists of an AI machine learning image analysis software algorithm hosted on Viz.ai servers that analyzes NCCT scans for intracranial hemorrhage, and a mobile software module that receives notifications and enables previewing of non-diagnostic CT images via a mobile app.

Performance

Performance testing used 387 non-contrast CT scans from two US clinical sites with roughly half positive for ICH and half negative. Sensitivity was 95% and specificity was 96%, exceeding preset goals of 80%. The ROC AUC was 0.97, and the average notification time was 0.49 minutes compared to 18.3 minutes standard of care, indicating increased speed of specialist notification.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
1/26/2021
1 month
2
FDA Approval
3/23/2021

Other devices from Viz.ai, Inc.

Viz HDS, Viz Volume Plus, Viz ICH+
2024 • 510K
Viz HCM
2023 • DE NOVO
Viz AAA
2023 • 510K

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