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510(k) Data Aggregation

    K Number
    K182177
    Device Name
    Accipiolx
    Manufacturer
    MaxQ-Al Ltd.
    Date Cleared
    2018-10-26

    (77 days)

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

    MaxQ-Al Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. Accipiolx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. Accipiolx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. 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 cases.
    Device Description
    Accipiolx is a software device designed to be installed within healthcare facility radiology networks to identify and prioritize non-contrast head CT (NCCT) scans based on algorithmically-identified findings of acute intracranial hemorrhage (alCH). The device, developed using computer vision and deep learning technologies, facilitates prioritization of CT scans containing findings of alCH. There are two main components of the software device: (1) the Accipiolx Agent and (2) the MaxQ-Al Engine. The Agent serves as an active conduit which receives head CT studies from a PACS and transfers them to the Engine. After successful processing of a case via the MaxQ-Al Engine, the Accipiolx Agent receives the Engine results and returns them to the PACS or workstation for use in worklist prioritization. Accipiolx works in parallel to and in conjunction with the standard care of workflow. After a CT scan has been performed, a copy of the study is automatically retrieved and processed by Accipiolx. The device performs identification and classification of objects consistent with alCH, and provides a case-level indicator which facilitates prioritization of cases with potential acute hemorrhagic findings for urgent review.
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