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510(k) Data Aggregation

    K Number
    DEN170073
    Device Name
    ContaCT
    Manufacturer
    Viz.Al, Inc.
    Date Cleared
    2018-02-13

    (137 days)

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

    Viz.Al, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. ContaCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. ContaCT is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
    Device Description
    ContaCT is a notification only, parallel workflow tool installed across the stroke network in healthcare facilities to identify and communicate images and information of specific patients to a neurovascular specialist (b) (4) patients' CT scan. As discussed below, the device facilitates a workflow parallel to the standard of care workflow, and, in the case of a true positive study, results in a notified specialist entering the standard of care workflow earlier. The device works in parallel to the standard of care workflow. After a CTA has been performed, a copy of the study is automatically sent to and processed by ContaCT. ContaCT performs vessel segmentation and quantifies image characteristics consistent with a Large Vessel Occlusion (LVO) in a large cerebral vessel, and sends a notification based on a fixed threshold to a neurovascular specialist, recommending review of these images. Notifications provide links to preview a compressed version of the identified study on a mobile application. ContaCT is a software only device that can be segmented into three components: (1) Image Forwarding Software, (2) Image Processing and Analysis Software, and (3) Image Viewing Software.
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