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510(k) Data Aggregation

    K Number
    K013994
    Device Name
    MODIFICATION TO VIEWSEND MEDICAL
    Manufacturer
    Date Cleared
    2002-02-01

    (59 days)

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

    KLT TELECOM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When installed on an appropriate PC-based platform, VIEWSEND Medical software is intended to provide the medical professional with the capability to view, retrieve, store, import, process, collaborate, and/or transmit medical images in order to render a diagnosis. Options allow for teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security. castommande and ass, suase, can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, satchire, and, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or server.
    Device Description
    When integrated into an appropriate PC-based platform, VIEWSEND Medical imaging software contains several modules to enable the medical professional to view, retrieve, store, import, process, collaborate, and transmit medical images in order to render a diagnosis. VIEWSEND Medical software can include teleradiology, telemedicine, and videoconferencing in an open system that runs under the Microsoft Windows 98/2000/NT operating system. VIEWSEND Medical software is modular and able to provide one or more of the VIEWSEND standard features to match clinical needs - teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security. Existing medical films can be digitized, scanned, and stored as DICOM 3.0 images. Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, or plain old telephone system (POTS). The DICOM option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers. VIEWSEND Medical software allows medical professionals in remote locations to view, discuss and consult on the same images of a patient case file. This can be done with live cameras and scopes or by sending high-resolution files that have been scanned into the remotely located PC. VIEWSEND Medical software allows images to be sent from the archive files of one machine, and be transported to a different server, so that images from previous examinations may be compared with new more up-to-date images. These stored images can be at the physician request, sent in advance to save time and bandwidth during crucial consultations. Communications between VIEWSEND systems can use industry standard 128-bit encryption, and/or JPEG or JPEG2000 compression.
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    K Number
    K962225
    Device Name
    VIEWSEND MEDICAL MODEL 1200
    Manufacturer
    Date Cleared
    1996-10-25

    (137 days)

    Product Code
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    KLT TELECOM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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