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510(k) Data Aggregation

    K Number
    K192167
    Device Name
    CuraRad-ICH
    Manufacturer
    Date Cleared
    2020-04-13

    (248 days)

    Product Code
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    CuraCloud Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CuraRad-ICH 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. CuraRad-ICH analyzes cases using deep learning algorithms to identify suspected ICH findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. CuraRad-ICH is not intended to direct attention to specific portions of an image or to anomalies other than acute ICH. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT studies.
    Device Description
    CuraRad-ICH is software as a medical device (SaMD) that detects intracranial hemorrhage (ICH) condition by analyzing non-contrast CT images. The software needs to be integrated with a third-party worklist application to receive analysis requests and the corresponding DICOM images, and return the ICH findings (whether suspected ICH is found) to the worklist to alert the radiologists. To help radiologists triage and prioritize reading of images for patients with ICH, CuraRad-ICH uses deep learning methods to automatically detect acute ICH in non-contrast head CT scans. The software analyzes the input image and returns a binary prediction as to whether the exam suggests the presence of acute ICH.
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