HealthICH
Zebra Medical Vision Ltd.HealthICH is an AI software tool designed to analyze non-contrast head CT scans and identify suspected cases of intracranial hemorrhage. It notifies the clinician via the PACS/workstation to prioritize these urgent cases, helping reduce the time to diagnosis and potentially improving patient care. It operates alongside standard workflows and assists clinicians by flagging critical findings for faster review.
Intended Use
Software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage, providing case-level output for worklist prioritization or triage. Not for standalone clinical decision making or ruling out hemorrhage.
Technology
HealthICH uses an AI algorithm to analyze non-contrast head CT scans, identifies suspected intracranial hemorrhage, and sends results to the PACS/workstation for worklist prioritization. It does not mark images or provide specific localization, working alongside standard workflows. It includes input validation, analysis algorithm, integration to PACS via Zebra Imaging Analytics platform, and error reporting modules.
Performance
Performance was validated retrospectively on 427 anonymized head CT cases with 199 positive and 228 negative for intracranial hemorrhage, adjudicated by certified neuroradiologists. HealthICH showed sensitivity of 94.47% and specificity of 92.54%, with an average triage processing time of 48.67 seconds, demonstrating safety and effectiveness equivalent to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/22/2019
3 months - 2
FDA Approval
6/13/2019
Other devices from Zebra Medical Vision Ltd.
- HealthPPT2021 • 510K
- HealthCCSng2021 • 510K
- HealthJOINT2020 • 510K
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