Rapid SDH
iSchemaView, Inc.Rapid SDH is an AI-based software that helps radiologists prioritize and triage head CT scans by detecting suspected hemispheric subdural hemorrhage (SDH). It analyzes non-contrast head CT images in parallel with standard readings and provides timely notifications with preview images for informational use, assisting clinicians in workflow management to improve patient care.
Intended Use
Rapid SDH is a radiological computer aided triage and notification software indicated for use in the triage and notification of hemispheric SDH in non-enhanced head images to assist trained radiologists in workflow triage by providing notification of suspected hemispheric SDH findings.
Technology
Rapid SDH operates as an AI/ML module within the Rapid Platform analyzing non-contrast head CT images to detect suspected hemispheric SDH. It processes DICOM images, manages jobs, executes imaging modules and issues priority notifications with compressed preview images without altering original images, running in parallel to standard workflow.
Performance
Performance testing included a retrospective, blinded, multicenter study on 310 head CT scans with 147 positives and 163 negatives for subdural hemorrhage, showing sensitivity of 92.4% and specificity of 98.7%. Processing time median was 45 seconds. Performance was robust across age, gender, SDH subtypes, slice thickness, and different CT manufacturers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/14/2023
2 months - 2
FDA Approval
10/25/2023
Other devices from iSchemaView, Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid Aneurysm Triage and Notification2023 • 510K
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