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510(k) Data Aggregation

    K Number
    K970064
    Device Name
    AMICAS WEB/INTRANET IMAGE SERVER
    Manufacturer
    AUTOCYT GROUP, INC.
    Date Cleared
    1997-03-17

    (69 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUTOCYT GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry-standard communications format (DICOM 3.0). The software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation.
    Device Description
    AMICAS is an integrated client-server software system designed to allow access to medical inages by radiologists, referring physicians and other licensed professionals. This product is intended to allow the review of images on a digital Picture Archive and Communication System (PACS) network using a personal computer or workstation configured for standard Internet access. The server component of AMICAS is installed on a computer configured with connections to both the PACS and the Internet. Typically, images will be accessed through a World Wide Web (WWW) browser (the client) such as Microsoft Internet Explorer or Netscape Navigator. Radiology workstations can Query and Retrieve images from AMICAS using standard DICOM protocols. AMICAS can be used for image distribution within a hospital, a managed care organization or an isolated imaging center. It can also serve as a telemedicine link between widely separate organizations.
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