LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060505
    Device Name
    VOXAR 3D ENTERPRISE, MODEL 6.1
    Manufacturer
    BARCOVIEW MIS EDINBURGH
    Date Cleared
    2006-03-29

    (30 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VOXAR 3D ENTERPRISE, MODEL 6.1

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.

    The Voxar 3D product family provides several levels of functionality to the user :-

    • Basic analysis tools they use on a daily basis, such as 2D review, orthogonal Multi Planar ● Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc
    • Tools for in-depth analysis, such as segmentation, endoscopic review, colour VR slab, 3D . volume review, path definition and boundary detection, PET imagery analysis, etc
    • Specialist tools and workflow enhancements for specific clinical applications which . provide targeted workflows, custom UI, targeted measurement and reporting functions including Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), Calcium Scoring (which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Voxar 3D Product Family and does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use, but it does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself or in accompanying clinical validation reports, which are not part of this FDA clearance letter.

    Therefore, I cannot provide the requested information from the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1