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510(k) Data Aggregation

    K Number
    K211713
    Device Name
    AngioCloud Service
    Manufacturer
    Date Cleared
    2022-04-28

    (329 days)

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

    AngioCloud, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AngioCloud Service enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. General functionalities are provided such as: - Segmentation of neurovascular structures - · Centerline calculation - · Visualization of 3D vascular images - · Measurement and annotation tools - · Case sharing and reporting tools Information provided by the software is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
    Device Description
    The AngioCloud Service is a standalone web-application which intends to receive a 3D rotational angiography (3D-RA) DICOM dataset and provide interactive views to physicians for the visualization and measurement of cerebral vasculatures during preoperational planning. Physicians can query a 3D-RA dataset directly via the AngioCloud Service provided that they have an internet browser with access to the internet. General functionalities are provided such as: - Segmentation of neurovascular structures ● - . Centerline calculation - Visualization of 3D vascular images - . Measurement and annotation tools - Case sharing and reporting tools The AngioCloud Service runs as a web application on a standard Windows or Mac OS X based computer and can also be accessed on mobile web browsers, but with limited software functionalities enabled. The AngioCloud Service does not use any artificial intelligence or machine learning functionality and the main segmentation algorithm is based on level-set methods. The Visualization Toolkit (VTK) and Vascular Model Toolkit (VMTK) serve as important software libraries that the underlying algorithm of AngioCloud Service leverages for a number of computational operations such as 3D segmentation, geometric analysis, mesh generation, and surface data analysis for image-based modeling of blood vessels. The device does not contact the patient nor does it control any life-sustaining devices. Information provided by the AngioCloud Service is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
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