Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images to assist hospital networks and radiologists by flagging and communicating suspected intracranial hemorrhage findings to support prioritization of image review.

Technology

BriefCase is a software system comprising three modules (Hospital Server, Cloud Server, Worklist Application) that receives DICOM images, processes them with a deep learning AI algorithm to detect suspected intracranial hemorrhage. It sends notifications and compressed preview images to radiologists' desktops for parallel workflow triage without altering original images or removing cases from reading queues.

Performance

A retrospective, blinded, multicenter study with 198 cases showed BriefCase sensitivity of 93.6% and specificity of 92.3% for detecting intracranial hemorrhage. Time-to-notification averaged 4.5 minutes compared to 72.6 minutes for standard care exam opening, potentially saving 68 minutes in triage prioritization for true positive cases.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/12/2018

    4 months
  • 2

    FDA Approval

    8/1/2018

Other devices from Aidoc Medical, Ltd.

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