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510(k) Data Aggregation

    K Number
    K241546
    Device Name
    aiCockpit AI Viewer
    Manufacturer
    Date Cleared
    2025-02-26

    (271 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fovia, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Al Viewer is software for clinical review intended for use in General Radiology and other healthcare imaging applications. Al Viewer is intended to be used with off the shelf computing devices. Al Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari. Al Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Al software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Al Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images.
    Device Description
    Al Viewer is a stand-alone software as medical device (Stand-alone SaMD) for clinicians able to use web browsers at client stations to view DICOM image data. It is intended to provide image and related information to render and interact with Al findings and annotations from Lung Nodule detection Al algorithms, but it does not directly generate any potential findings or diagnosis. Al Viewer allows trained medical professionals to perform 2D, MPR & 3D image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack scroll, and magnify. Al Viewer is also capable of organizing all the images and presenting them in a zero-footprint, web user interface, allowing the users to view images in their preferred layout. Al Viewer allows trained medical professions with the Al Findings such as accept/reject/edit. Editing tools include selecting descriptive features for findings as well as allowing the physician to control editing quantifiable measurements first computed by AI such as lengths and volumes. Al Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari.
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