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Intended Use

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 (ICH). It analyzes cases using deep learning algorithms to identify suspected ICH findings and makes case-level output available to a PACS/workstation for worklist prioritization or triage. It is not intended to direct attention to specific portions of an image or anomalies besides acute ICH, nor used as a standalone clinical decision tool.

Technology

The device uses deep learning techniques to automatically analyze non-contrast head CT scans and provide passive notifications to radiologists via PACS/workstation when features suggestive of acute intracranial hemorrhage are identified. The software does not highlight specific image locations and supports worklist prioritization and triage.

Performance

A retrospective, blinded, multisite clinical validation study on 288 U.S. CT scans (132 positive for ICH) demonstrated the system achieves 94.7% sensitivity, 94.9% specificity, and an AUROC of 0.983. The processing time per study averages 35 seconds, comparable to the predicate device. Subgroup analyses showed reliable performance across genders, ages, CT manufacturers, slice thickness, and ICH types.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/11/2023

    5 months
  • 2

    FDA Approval

    10/4/2023

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