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510(k) Data Aggregation

    K Number
    K962589
    Device Name
    AURORA DIAGNOSTIC WORKSTATION
    Manufacturer
    AURORA TECHNOLOGY, INC.
    Date Cleared
    1996-09-20

    (80 days)

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

    AURORA TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Aurora Diagnostic Workstation is identical to other commercially available medical imaging workstations.
    Device Description
    The Aurora Medical Imaging Workstation consists of a personal computer, a "Processor "board set for decompression of tiled, stored images; up to eight high resolution (1024 x 1280) monochrome CRT monitors; up to eight video controller boards to display and store the image; a retrieval monitor; and proprietary software for retrieval, image handling and the user interface.
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