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510(k) Data Aggregation

    K Number
    K211788
    Device Name
    HALO
    Manufacturer
    Date Cleared
    2021-07-08

    (29 days)

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

    Nico.Lab B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HALO is a notification only cloud-based image processing software artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified condition and to directly notify an appropriate medical specialist. HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing CT angiograms of the brain acquired in an acute setting. After completion of the data analysis, HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image. The intended users of HALO are defined as medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency department where stroke patients are administered. The include physicians such as neurologists, radiologists, and/or other emergency department physicians. HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare and Philips.
    Device Description
    HALO is a notification only, cloud-based clinical support tool which identifies image features and communicates the analysis results to a specialist in parallel to the standard of care workflow. HALO is designed to process CT angiograms of the brain and facilitate evaluation of these images using artificial intelligence to detect patterns suggestive of an intracranial large vessel occlusion (LVO) of the anterior circulation. A copy of the original CTA images is sent to HALO cloud servers for automatic image processing. After analyzing the images, HALO sends a notification regarding a suspected finding to a specialist, recommending review of these images. The specialist can review the results remotely in a compatible DICOM web viewer.
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