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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 to assist hospital networks and trained radiologists by flagging and communicating suspected positive findings of intracranial hemorrhage.

Technology

RAPID ICH integrates within the RAPID platform, processing non-contrast head CT DICOM images using a deep learning AI algorithm to automatically detect suspected intracranial hemorrhage. The software runs on hospital servers or virtual machines, sends notifications with compressed image previews via PACS, email, and mobile app, and operates in parallel with standard radiological workflows without altering the original images.

Performance

A retrospective, blinded, multicenter study evaluated RAPID ICH on 336 NCCT head scans with and without ICH. Sensitivity was 89.9%, and specificity was 94.3%, exceeding the 80% goal. Time to notification was 2.28 minutes, including image acquisition, de-identification, analysis, and alert delivery.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/6/2019

    4 months
  • 2

    FDA Approval

    3/31/2020

Other devices from iSchemaView Incorporated

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