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510(k) Data Aggregation

    K Number
    K992352
    Device Name
    ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
    Manufacturer
    INTELERADIOLOGY, INC.
    Date Cleared
    1999-09-29

    (77 days)

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

    INTELERADIOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iTR2000 is a software communications tool intended to be used in the transportation, storage and retrieval of digital medical images for the purpose of off-site review.
    Device Description
    iTR2000™ is a stand-alone software product which may be marketed as a software-only product, as well as for use in conjunction with standard PC hardware, off-the-shelf software or third-party teleradiology/PACS software. iTR2000™ provides short-term remote access to medical images by radiologists, referring physicians and other licensed professionals, utilizing a personal computer or workstation with internet access. Images are securely stored on a internet website for on-demand remote retrieval via the iTR2000™ software, or via a standard web browser without the use of propriety software. The iTR2000™ system employs the latest internet security techniques and meets all current federal medical communications standards including recent proposals from HCFA and HHS. iTR2000™ is primarily intended to allow the transmission, retrieval and review of images produced by imaging equipment otherwise not part of a digital Picture Archive and Communication System (PACS) network or legacy equipment not compatible with ACR/NEMA DICOM 3.0. Conventional film-based images can be optically digitized and stored in a standard image format, such as JPEG. iTR2000™ can also be configured to web-enable third-party DICOM-capable teleradiology/PACS systems in low-volume environments for remote or on-call activities. iTR2000™ is designed for use primarily with small-matrix imaging modalities, such as images produced by Computed Tomography (CT), Ultrasound (US), Magnetic Resonance Imaging (MRI), Nuclear Medicine (NM), digital flourography and digital angiography. The use of images produced by large-matrix imaging systems, such as digitized radiographic films and computed radiography or mammography. requires the use of digitization and viewing equipment which exceed the stated minimum requirements for the standard iTR2000™ system. iTR2000™ does not control the actual image-taking system (i.e. x-ray, MRI, ultrasound or scintography machines).
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