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510(k) Data Aggregation

    K Number
    K072653
    Device Name
    3VISEON/SURGERY
    Manufacturer
    3MENSIO MEDICAL IMAGING BV
    Date Cleared
    2008-01-24

    (126 days)

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

    3MENSIO MEDICAL IMAGING BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3viseon/surgery™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, vascular measurements, annotations, reporting, distribution, etc. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.
    Device Description
    3viseon/surgery™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital Mammograms). 3surgery is an advanced 2D and 3D visualization solution that enables surgeons to quickly and reliably prepare for various types of surgery, by combining 2D scan slices into comprehensive 3D models of the patient. The software device should not be used during a surgical procedure. 3viseon/surgery™ works with all major medical image formats and can access multiple data stores, across networks or on CD-ROM / DVD. The software runs on any modern Windows based computer with a 3D graphics card that meets the minimum requirements, eliminating the need for specialized hardware.
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    K Number
    K043097
    Device Name
    3VISEON
    Manufacturer
    3MENSIO MEDICAL IMAGING BV
    Date Cleared
    2004-11-19

    (10 days)

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

    3MENSIO MEDICAL IMAGING BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3viseon™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored. communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed 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 FDA. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
    Device Description
    3viseon™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, fransfer, display, storage, and digital processing of medical images (including digital Mammograms). The 3viseon software allows you to select patient series from various data sources, view them in 2D or 3D mode and process the images with the help of a comprehensive set of tools: - Data Management for a detailed description on how to select patient studies from one or more data sources; - 2D Viewing Mode - for a detailed description on how to view images in 2D mode and process them: - -3D Viewing Mode - for 3D imaging.
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