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510(k) Data Aggregation

    K Number
    K201310
    Device Name
    Accipiolx
    Manufacturer
    Date Cleared
    2020-08-07

    (84 days)

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

    MaxQ Al Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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, which utilizes deep learning technologies, facilitates prioritization of CT scans containing findings of alCH. Accipiolx receives CT scans identified by the Accipio Agent or other compatible Medical Image Communications Device (MICD), processes them using algorithmic methods involving execution of multiple computational steps to identify suspected presence of alCH, and generates a results file to be transferred by the Accipio Agent or a similar MICD device for output to a PACS system or workstation for 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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