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Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software. Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Xelis Dental 2.0, is a software device used for viewing and manipulating DICOMcompliant images from CBCT (Cone beam computed tomography). Xelis Dental 2.0 is an advanced, easy-to-use dental software providing various tools to dental facilities. Xelis Dental 2.0. provides a practical tool for 3D (three dimensional) and 2D (two dimensional) viewing to optimize dental treatment planning and placement. This stand-alone, Windows-compatible software provides 3D volume rendering (VR), multi-planar reconstruction (MPR) and image segmentation. Xelis Dental 2.0, offers dental implant planning, canal draw, bone density assessment, segmentation and report functionalities. The subject device (Xelis Dental 2.0) is based upon the predicate device, Xelis Dental, (K102684). Xelis Dental 2.0 has updated the software from the predicate to reflect current computer technology and also has a number of new/improved functions. Both the subject device and the predicate are from INFINITT Healthcare Co. Ltd.

INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data. INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.

Infinitt RT PACS, is a radiation therapy image Management solution dedicated to the oncology department. By using Infinitt RT PACS, the treatment planning system of various vendors can be stored and managed. It also transfers DICOM RT type plan images and information to EMR through HL7or database links. Infinitt RT PACS, provides the function to acquire and view DICOM data generated from RTP (Radiotherapy Planning) System in the form of DICOM C-Store. Supported data includes CT (Computerized Tomography) DICOM image, DICOM RT PLAN data, DRR (Digitally Reconstruct Radiography) image and DICOM RT-Structure, dose information of DICOM RT-Dose and DVH (Dose-Volume Histogram) data. In addition, it supports Axial, Coronal, Sagittal view to check the location of the corresponding Axial CT image and dose distribution to Coronal, Sagittal View through scout line. Infinitt RT PACS, provides DICOM conformant services for both short and long-term image storage and retrieval of digital image data. The application uses DICOM as the interface to the external world and enables interoperability between different devices. Infinitt RT PACS, accepts DICOM association requests for the purpose of storing images and for query and retrieval of images. It also initiates DICOM association requests for the purpose of sending images to an external application entity.

Infinitt PACS 7.0,"is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

Infinitt PACS 7.0™ device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the location as the modality. With its Web features, it is possible to review, modify, and approve studies located in a remote server. INFINITT PACS is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed. Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM view station running on Windows 7/8.1/10. Infinitt PACS 7.0 is an integral component of INFINITT's complete INFINITT PACS/RIS solution. Infinitt PACS 7.0 fully supports DICOM standards and such functions as advanced DICOM viewing, Hanging Protocol, various 3D display such as MPR, Volume Rendering, MIP and fusion. Infinitt PACS 7.0 allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images. With Infinitt PACS 7.0, users can access their own diagnostic environment anywhere, anytime. This is made possible because Infinitt PACS 7.0 is deployed through a network and supports hanging protocol. Also, Infinitt PACS 7.0 uses JPEG 2000 features so that it takes less time to transfer images through a network. Infinitt PACS 7.0 is based upon the INFINITT G3 PACS (predicate device). The features and functions of Infinitt PACS 7.0 have similar features and functions of G3 PACS with an updated operating system due to current advances in computer technology.