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510(k) Data Aggregation

    K Number
    K062062
    Device Name
    VOYAGER PACS SYSTEM
    Manufacturer
    Date Cleared
    2006-09-11

    (53 days)

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

    VOYAGER IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Voyager PACS System™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices. scanners. imaging gateways, etc.). Images and data can be captured. stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    Voyager PACS is a web enabled PACS system that provides medical images of any patient to any doctor, anytime, anywhere. Voyager PACS is a server based system that allows image archiving, storage, management and distribution. The system receives images from Modalities via DICOM or from other sources (i.e. Teleradiology). Images are stored on the PACS Server. The studies and images on this server can be viewed, reported and manipulated by the Voyager Diagnostic workstations connected to the PACS server via LAN, WAN or Internet connection. Voyager Integrator provides seamless interface to the Radiology Information System (RIS) via HL7, allowing information between the Voyager PACS and the RIS to be shared and exchanged.
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