Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K982535
    Device Name
    INSIGHT DIAGNOSTIC IMAGING WORKSTATION
    Manufacturer
    NEO IMAGERY TECHNOLOGIES, INC.
    Date Cleared
    1998-12-21

    (154 days)

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

    NEO IMAGERY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
    Device Description
    The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft Windows NT™ operating system makes the InSight™ Diagnostic Imaging Workstation easy to use and capable of being integrated with your other computer needs.
    Ask a Question
    K Number
    K965179
    Device Name
    INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
    Manufacturer
    NEO IMAGERY TECHNOLOGIES, INC.
    Date Cleared
    1997-07-03

    (191 days)

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

    NEO IMAGERY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InSight™ Diagnostic Imaging Workstation must be used by or on the order of a physician. The system receives digital information from scanning devices and manipulates image data for the purpose of image characterization, enhancement, communication, archiving, and real-time 3D visualization. The system is designed as an aide to trained medical practitioners in the diagnostic process. Only qualified personnel should service system hardware and software.
    Device Description
    The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visualization, communication, archiving, characterization, and image enhancement with digital information received from medical scanning devices. System utilizes IBM compatible PC with Intel "X"86 family microprocessors and Microsoft Windows NT™ operating system for ease of maintenance and cost.
    Ask a Question

    Page 1 of 1