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510(k) Data Aggregation

    K Number
    K102000
    Device Name
    IMAGYS
    Manufacturer
    KEOSYS S.A.S.
    Date Cleared
    2010-10-12

    (89 days)

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

    KEOSYS S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the management, the viewing, the reviewing, the storage and archiving of imaging data, and the related documentations, acquired from a variety of imaging devices. Imagys can also support the management of the imaging parts of a clinical trial workflow including the following steps : quality control, data processing and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical end users are trained medical professionals and clinical trial actors. The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards, data accepted by the Imagys solution. It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data. This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
    Device Description
    Imagys is a computing and software solution designed by experts in medical imaging and telecommunications for the collection, quality control, processing, analysis and visualization of imaging data. Imagys can help to execute olinical trials with secure transfer, management, viewing, printing, storage and archiving of data.
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    K Number
    K070606
    Device Name
    VISIO+CD VIEWER# KPSCDVE01
    Manufacturer
    KEOSYS S.A.S.
    Date Cleared
    2007-04-24

    (50 days)

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

    KEOSYS S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography. Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM. Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.
    Device Description
    Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images by another Medical Device. Visio+ CD Viewer operates only on a computer that meets the following requirements: Windows 2000/XP, Pentium III 1 GHz or better, 512 Mo RAM, minimum display resolution 1024x768, a CD or DVD drive. Visio+ CD Viewer provides tools for image review and manipulation.
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