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510(k) Data Aggregation

    K Number
    K063037
    Device Name
    CENTARISONE RIS/PACS
    Manufacturer
    CENTARISONE, LLC
    Date Cleared
    2006-10-18

    (15 days)

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

    CENTARISONE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.
    Device Description
    The CentarisOne™ RIS/PACS is a comprehensive DICOM and IHE compliant radiology software based solution for small to mid-sized imaging centers. The RIS maintains control over all patient related information. The product integrates the imaging aspect with the front office details of the imaging center. It provides all users of the system with more information about the activities of a patient. This all leads to a smoother workflow and better patient care. The PACS component manages the image storage and image display to end-users while tightly integrated into the radiology information system (RIS) to provide users with more patient information resulting in a tighter work-flow.
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