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510(k) Data Aggregation

    K Number
    K223443
    Device Name
    Viz AAA
    Manufacturer
    Date Cleared
    2023-03-17

    (123 days)

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

    Viz. ai, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care. Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA is limited to analysis of imaging data and should not be used inlieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.
    Device Description
    Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The software automatically receives and analyzes CT angiogram (CTA) imaging of the abdomen for the presence of an aortic aneurysm using an artificial intelligence algorithm and highlights suspect patient imaging in a standalone application for study list prioritization or triage by vascular or endovascular specialists in parallel to standard of care image interpretation. Viz AAA is a combination of software modules that consists of an image analysis software algorithm and mobile application software module. The Viz AAA Image Analysis Algorithm is an artificial intelligence machine learning (Al/ML) software algorithm that analyzes CTA images of the abdomen for an aortic aneurysm. Images acquired during patient care are forwarded to Viz.ai's Backend server where they are analyzed by the Viz AAA artificial intelligence algorithm for an abdominal aortic aneurysm. Viz AAA includes a mobile software module that enables the end user to view cases identified by the Viz AAA algorithm to contain a suspected abdominal aortic aneurysm. The Viz AAA mobile software module is implemented into Viz.ai's generic non-diagnostic DICOM image mobile viewing application, Viz VIEW, which displays CTA scans that are sent to the Backend server. When the Viz AAA Mobile Software module is enabled, studies determined by the algorithm to contain a suspected abdominal aortic aneurysm are highlighted in the standalone mobile application for study list prioritization or triage in parallel to ongoing standard of care. The user can also view compressed preview images and a non-diagnostic preview of the analyzed CTA scan of the patient through the mobile application. The preview images and additional patient imaging available through the standalone mobile application are meant for informational purposes only and not intended for diagnostic use. The results of Viz AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists who read the original medical images are responsible for the diagnostic decision.
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