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510(k) Data Aggregation

    K Number
    K100094
    Device Name
    CARESTREAM IMAGE SUITE
    Manufacturer
    CARESTREAM HEATLH, INC.
    Date Cleared
    2010-03-11

    (57 days)

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

    CARESTREAM HEATLH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. This excludes mammography applications in the United States.
    Device Description
    CARESTREAM Image Suite is a stand-alone, self-contained radiographic imaging system designed to provide a low-cost platform to manage medical images, reports, patient/exam information and workflow in small clinics. The system performs capture, processing, review, archiving, and printing of radiographic images as well as report writing and printing and is designed to run on a PC workstation. The CARESTREAM Image Suite is designed to be simple and intuitive to both use and service. CARESTREAM Image Suite is designed as a hardware-independent system and may be interfaced with verified and validated image acquisition devices from both Carestream Health and 3rd party vendors, Carestream Health PACS system, and other 3rd party PACS systems. The system will acquire an image from either a DirectView Classic CR or a Point-of-Care 140/145 or 360 CR and be PC and monitor independent.
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