Rapid ICH
iSchemaView Inc.Rapid ICH by iSchemaView Inc. is a medical software that uses artificial intelligence to analyze head CT scans for signs of intracranial hemorrhages such as IPH, IVH, SAH, and SDH. It helps hospitals and radiologists prioritize CT images needing urgent attention by providing notifications about suspected hemorrhages, enabling faster diagnosis and treatment without altering the original medical images or replacing diagnostic interpretation.
Intended Use
Rapid ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. It assists hospital networks and trained radiologists in workflow triage by flagging and communication of suspected pathologies for intracranial hemorrhages (IPH, IVH, SAH, SDH).
Technology
Rapid ICH is an AI/ML-based software module that processes non-contrast head CT scans on a server or standalone desktop application. It uses a neural network algorithm to analyze images, identifies suspected positive ICH findings, and generates priority notifications including compressed preview images for triage purposes. It operates in parallel to standard of care imaging workflows without altering original images.
Performance
The software was validated in a retrospective, blinded, multicenter, multinational study of 314 head CT cases (148 ICH positive, 166 negative). It achieved 96.8% sensitivity and 100% specificity for detecting ICH, exceeding the 80% performance goal. Time to notification was significantly faster (0.65 min) compared to standard care time to exam open (72.6 min). Performance was consistent across genders, age groups, ICH subtypes, slice thicknesses, scanner manufacturers, and image reconstruction methods.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/19/2022
3 months - 2
FDA Approval
9/12/2022
Other devices from iSchemaView Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 510K
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