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510(k) Data Aggregation

    K Number
    K970525
    Device Name
    STATNET
    Manufacturer
    GORCA SYSTEMS, INC.
    Date Cleared
    1997-04-16

    (64 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    GORCA SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.
    Device Description
    StatNet is a network of image display, processing, and archiving modules composed of general purpose, personal computer level, digital hardware; commercial, general purpose digital communication hardware; general purpose operating systems and communications software; medical image analysis and processing software developed by others; and proprietary software modules developed by GORCA that integrate the preceding components into a complete system. Images enter the network on DICOM-3 CD-ROM media.
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