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510(k) Data Aggregation

    K Number
    K093444
    Device Name
    EXAPACS
    Date Cleared
    2010-02-04

    (91 days)

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

    MEDINCOM TECHNOLOGY CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic. ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
    Device Description
    ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic. ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.
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