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510(k) Data Aggregation

    K Number
    K090668
    Device Name
    VISION TOOLS
    Manufacturer
    Date Cleared
    2009-06-23

    (102 days)

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

    VISION TOOLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K063439
    Manufacturer
    Date Cleared
    2007-01-22

    (70 days)

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

    MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS

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

    Millennium Technology's Vision Tools is intended to be used as a complete medical imaging and information solution that helps users in the Radiology/Tele-Radiology fields. It is considered one of the most powerful radiology viewing stations for PACS systems. Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc.

    With Vision Tools 3Dview, high quality 3D volumes from CT, MRI and ultrasound can be created with volume rendering, MPR, MIP, color rendering, cut planes, volume rotation and much more. The large number of image processing tools, filters, annotations, measurements, windowing and display functions can be customized for viewing. Lossy compressed mammogrphic images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA,

    Device Description

    Millennium Technology's Vision Tools is intended to be used as a complete medical imaging and information solution that helps users in the Radiology/Tele-Radiology fields. It is considered one of the most powerful radiology viewing stations for PACS systems. Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc.

    With Vision Tools 3Dview, high quality 3D volumes from CT, MRI and ultrasound can be created with volume rendering, MPR, MIP, color rendering, cut planes, volume rotation and much more. The large number of image processing tools, filters, annotations, measurements, windowing and display functions can be customized for viewing.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for the Millennium Technology Vision Tools device. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, which primarily focuses on the regulatory clearance for the device and its intended medical use. It does not include a scientific study report or performance data.

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