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510(k) Data Aggregation

    K Number
    K171534
    Device Name
    SurgicalPreview
    Manufacturer
    Endo Vantage, LLC
    Date Cleared
    2017-11-08

    (167 days)

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

    Endo Vantage, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgicalPreview enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview also allows for the ability to computationally model the placement and deployment of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of CT scan images for 2D review and 3D reconstruction - Measurement and annotation tools - 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
    SurgicalPreview" is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview™ provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview™ enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview™ can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. 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 judgement and analysis of the patient's condition.
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