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510(k) Data Aggregation

    K Number
    K973805
    Device Name
    IMAGEACCESS SYSTEM
    Manufacturer
    STORCOMM, INC.
    Date Cleared
    1998-01-02

    (88 days)

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

    STORCOMM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to allow storage and retrieval of medical images for purposes of assisting in the diagnosis and/or treatment of diseases.
    Device Description
    The ImageACCESS® system is a complete clinical image management system providing direct capture, retrieval, storage, and transmission of images, reports and patient demographics. These images include, but are not limited to, Flat film Radiology, computer Tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET). Images from such devices are directly recorded/retrieved on/from optical disk recorders.
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