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510(k) Data Aggregation

    K Number
    K032157
    Device Name
    TELEMIS-MEDICAL SOLUTION
    Manufacturer
    Date Cleared
    2003-09-24

    (72 days)

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

    TELEMIS S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system.
    Device Description
    The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher. TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.
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