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Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care. Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.

i-CAT FLX V series / KaVo 3D eXam+ V series manufactured by Imaging Sciences International, is a Cone Beam Volumetric Tomography and Panoramic X-ray dental imaging system that consists of a scanner and a software package for image reconstruction. The two models, i-CAT FLX / KaVo 3D eXam+, are of identical design in the i-CAT Scanner family. The components of the system include the main affixed unit, the overhead, the gantry, the tube head, the X-ray source assembly and collimator, the receptor panel, and software package for image reconstruction. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The V series refer to 3 different fieldof-view configurations (V8, V10, V17) available on each model based on licensing of the acquisition software. The software package includes a device specific software package (SmartScan STUDIO) that is required to operate the i-CAT FLX System through a visual touchscreen interface and a post-processing imaging software. The modules within the device specific software perform the Image Acquisition, Quality Assurance, Device Calibration, and Image Reconstruction and Processing functionalities of the device. The software utilizes a modified Feldkamp algorithm for reconstruction. There is a basic DICOM viewer component (with limited image viewing capabilities) for the operator to ensure that the data collection and image processing are correct. Also provided with the device is a postprocessing imaging software, such as TxSTUDIO marketed under K123519. It is a volumetric imaging software designed specifically for dental clinicians, intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment. The imaging software reads DICOM data from dental CT machines, such as devices in the i-CAT family. Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain cross-sectional images of the head or neck. The proposed device is a CBCT dental system with 2 modes of operation: panoramic and CBCT.

Dexis Webview is a web-based software used for general dental and maxillofacial diagnostic image review that allows users alternate access to image data using a common web-browser. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. Dexis Webview is indicated for use only by prescription and by a trained and qualified dentist or dental technician.

Dexis Webview is a web browser-based accessory software application that allows users to access preexisting imaging data remotely. Users are able to view, enhance, annotate, compare, and export preexisting images using the Dexis Core database using a web-browser. The intended use of the device is to allow dentists to be able to diagnose remotely using a traditional web-browser running on a desktop PC or Apple Mac. The Dexis Webview Software is a software program for general dental and maxillofacial diagnostic imaging. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. It allows remote access to x-ray digital images acquired from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from intraoral dental cameras as long as they are stored in an accessible database.

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. VixWin Platinum Software has the following functionality which compares with the functionality provided for VixWin PRO predicate cleared under K060178. The functionality has been updated to remove legacy hardware no longer supported by the VixWin Platinum Software. - Controls scanning and intake of x-ray images from imaging plates with the Photo-Stimulable ● Phosphor (PSP) scanners. - Controls the direct capture of x-ray images from intra-oral sensors and extra-oral systems. ● - Allows View and capture color images from intra-oral and extra-oral cameras. ● - . Export and import digital images (such as those obtained by scanning a film). - . Process images with dental specific tools to enhance their diagnostic value. - . Analyze and enhance images to gather additional diagnostic information which may not be immediately apparent on initial visual inspection. - Obtaining and storing patient data pertaining to those images - Both the viewing of the images and storage of the images and their associated data. ● - Managing (locally and remotely) a database of patients and related data. - Allows the update of existing patient information and the creation and storage of new patient information in a database over the network. - . Allows access to patient files from multiple workstations via network connectivity. - . Allows printing images and image related information over the network. VixWin Platinum can be utilized either locally or over a networked environment. If VixWin Platinum is installed on several computers, the patient and image database can be shared among them and used from different workstations.

Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning and diagnostic support in adult and pediatic care. Devices of the i-C AT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.

i-CAT FLX was developed as an upgrade to the existing i-CAT Scanner. i-CAT FLX, manufactured by Imaging Sciences International, is a Cone Beam Volumetric Tomography and Panoramic X-ray dental imaging system that consists of a scanner and a software package for image reconstruction. It is a device in the i-CAT Scanner family. The components of the system include the main affixed unit, the overhead, the gantry, the tube head, the X-ray source assembly and collimator, the receptor panel, and software package for image reconstruction. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain crosssectional images of the head or neck. The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.

The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.