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510(k) Data Aggregation

    K Number
    K221491
    Device Name
    Anivia SG1000 Pump Console
    Manufacturer
    Date Cleared
    2023-02-03

    (256 days)

    Product Code
    Regulation Number
    870.4380
    Why did this record match?
    Applicant Name (Manufacturer) :

    APMTD, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
    Device Description
    The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.
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    K Number
    K063439
    Device Name
    MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS
    Manufacturer
    Date Cleared
    2007-01-22

    (70 days)

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

    MTD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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