Accipiolx
MaxQ-Al Ltd.Accipiolx is an artificial intelligence software tool designed to automatically analyze non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It integrates into hospital radiology networks to prioritize cases suggesting hemorrhage, enabling quicker review by clinicians and faster treatment decisions in acute care settings.
Intended Use
Accipiolx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. It analyzes cases using AI to identify suspected findings and provides case-level output for worklist prioritization or triage.
Technology
Accipiolx consists of two main software components: the AccipioIx Agent, which receives CT studies and communicates with the MaxQ-AI Engine. The engine uses deep learning and computer vision algorithms to identify acute hemorrhage findings from DICOM non-contrast head CT scans, generating a case-level indicator for prioritization. It operates in parallel to standard radiology workflow, returning results to PACS or workstations.
Performance
A retrospective study of 360 non-contrast head CT cases from over 30 US sites showed Accipiolx achieved 92% sensitivity and 86% specificity for detecting acute intracranial hemorrhage compared to expert neuroradiologist consensus. Average processing time per case was 4.1 minutes, comparable to similar predicate devices. These results support safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/10/2018
2 months - 2
FDA Approval
10/26/2018
Other devices from MaxQ-Al Ltd.
- Accipiolx2020 • 510K
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