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510(k) Data Aggregation

    K Number
    K101654
    Device Name
    IMPROVIS IMAGING SYSTEM
    Date Cleared
    2010-11-10

    (152 days)

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

    AMERICAN DENTAL PARTNERS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images. Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher. Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.
    Device Description
    Improvis Imaging is a software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intraoral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Once acquired, images can be enhanced for viewing by applying image processing functions which include resizing, rotating, embossing and sharpening of images. All images are compressed using lossless compression and stored in a shared relational database. The Improvis software interacts with the medical device software drivers, not the medical devices themselves. This interaction allows the computer system to acquire images captured via webcams, intraoral video cameras, panoramic x-rays, and other solid state sensors. These images are digitized by the outside vendor supplied medical devices, and then communicated via Improvis to the patient record. Once the images have been received by the system, they are embedded within the patient's dental record and can be accessed from any associated practice location. Radiographic images are compressed via a lossless system and can be manipulated and enhanced to suit the dental care provider's needs. Non-diagnostic images, such as scanned documents, may be compressed using non-lossless methods which optimize image quality and storage requirements. Original compressed images are stored prior to application of any image processing algorithms. Image processing by Improvis Imaging utilizes industry standard algorithms that do not result in the alteration of an image's or radiograph's content and will not introduce false data or modification into the acquired image. Improvis Imaging does not control the x-ray taking system and does not generate x-ray images directly from the physical device, but does provide the tools that permit the user to enhance images for diagnostic purposes. Improvis Imaging is a three tier application consisting of user interface, business objects (which provide communication between the user interface and database tiers), and database. The top two tiers of the program are written in Microsoft Visual Studio .NET C#, while the database components are written in Microsoft T-SQL. Improvis Imaging is a Microsoft Windows Forms (non-browser based) 32 bit application designed to run on Windows-compatible personal computers running the Microsoft Windows XP (or higher) operating system. Imaging processing functions are provided through the integration of a third party software development toolkit from Lead Technologies, Inc. Improvis Imaging is designed for use in a client-server environment in which the user interface portion of the application runs on an individual user's computer workstation as a Windows executable application. The Improvis Imaging shared database is installed on a single or clustered server running Microsoft SQL Server. The workstations and server are connected by a network using Microsoft Windows IP protocols. The application is designed for use in a Microsoft Windows Active Directory domain for authentication and access control, but can also run in non-Active Directory workgroups using internal Improvis access control. Improvis Imaging is not compliant with DICOM standards.
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