Rapid LVO
iSchemaView Inc.Rapid LVO is a software tool that helps hospitals and radiologists quickly identify and prioritize suspected cases of Large Vessel Occlusion (LVO) in head CT angiography images. It analyzes images using a software algorithm and provides notifications with preview images to assist clinical workflow, without replacing standard diagnostic procedures.
Intended Use
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images to assist hospital networks and radiologists by flagging and communicating suspected positive Large Vessel Occlusion (LVO) findings.
Technology
The device uses a software algorithm within the Rapid Platform to process DICOM-compliant CTA head images from scanners, analyze them for suspected LVO, and provide notifications and compressed preview images to clinicians in parallel to standard care workflow. It operates on servers or standalone desktop applications and sends results via PACS, email, and mobile app.
Performance
Performance validation showed Rapid LVO achieves high sensitivity (97.0%) and specificity (95.6%) with AUC of 0.99 in detecting LVO. Time to notification averages 2.86 minutes, meeting goals. Software validation and clinical testing confirm safety and effectiveness in clinical scenarios.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/8/2020
3 months - 2
FDA Approval
7/9/2020
Other devices from iSchemaView Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 510K
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