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INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, 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 inage 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.

The INFINITT ULIte™ system is PACS software capable of viewing and handling DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server. ULite is a device that displays medical images (including mammograms) and data from various imaging sources. In the Web environments, it is not needed to download any components, for example Active X, flash, flex, sliver lite, and the user can use this viewer in the browser. Typical users of this system are professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants). INFINITT ULite (subject device) is based upon the INFINITT G3 PACS (predicate device). The features and functions of ULite have a sub-set of the features and functions of G3 PACS with an updated operating system due to current advances in computer technology. INFINITT ULite Viewer: INFINITT ULIte is a medical image viewing application. It communicates with the INFINITT ULite Server to view the medical images. It supports various functions such as Windowing, Zoom, Pan, measurement, Cine play, and Report viewing. INFINITT ULite Server: INFINITT ULite Server only supports Microsoft Windows family. INFINITT ULite Server has been built by using Microsoft Visual C++ 2010, MFC library and .net framework. ULite software provides both 32-bit and 64-bit editions. When running on x64 editions of Microsoft Windows, the native x64-bit application of ULite must be provided for largememory support. The 32-bit application of ULite can be running on both 32bit and 64bit windows, while the maximum memory capacity might be different. Except the maximum memory support, the 32-bit edition and 64-bit edition must be virtually same in terms of functionalities.

Xelis Cardiac™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device is used by physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and are not performed automatically or semi-automatically by the software. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not by the software. Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists). This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Xelis Cardiac™ is a software device intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. Xelis Cardiac™ is a software device that consists of INFINITT Server (Database), and the software application which supports the DICOM standard with such functions as advanced DICOM viewing. The subject device allows users to take advantage of the images from various modalities in order to view data and images and the web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic software configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update. Xelis Cardiac™ supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions. Xelis Cardiac™ does not perform computer aided diagnosis and does not include anv automated or semi-automated processes for the detection of nodules or other diseases and is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software.

The Xelis Fusion™ is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists. Images (including mammographic) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. In addition, Xelis Fusion™ can be integrated with an institutions HIS or RIS for an integrated an electronic patient record. 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 approved monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.

XELIS Fusion is a Picture Archive and Communications System (PACS) software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS Fusion can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting. XELIS Fusion application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990. XELIS Fusion does not include any automated or semiautomated process for the detection of nodules or other shapes. XELIS 3D Fusion is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.

Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting. XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990. XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes. XELIS 3D is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.

Xelis DENTAL is a software device that is intended to provide tools for the reading and review of a DICOM compliant series of medical imagers which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data. Xelis DENTAL is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction). These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data. Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Xelis Dental is a PC-based application used for storing and displaying medical images. The application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems. The implementation of Xelis Dental DICOM interface has been carefully tested to assure compliance with the DICOM Conformance Statement. However, the Conformance Statement and the DICOM standard do not guarantee interoperability of INFINITT's products and products of other vendors. The user must compare the relevant Conformance Statements and if a successful interconnection should be possible, the user is responsible to specify an appropriate test suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM. Xelis Dental provides viewing of optimized images for 3D dental CT images. It comprises the following features. - 3D VR, MPR, MIP, minIP . - MPR rotating, curve, 3D zoom . - Nerve (canal) drawing . - Dental implant simulation and bone-density analysis . The subject device and the predicate devices are supplied to end users in both Windows 32 bit and 64 bit operations systems. XELIS DENTAL software can connect to other workstations, PACS server/software, and modalities, through the DICOM communication standard.

XELIS™ is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

XELIS is a CT colonography dedicated workstation designed to help radiologists to examine images. XELIS receives DICOM compliant CT images from a remote PACS server. Both primary 2D and primary 3D review modes are supported to meet the various needs of users. - Real-time and one-pass navigation based on an unfolded view to show complex inner wall of colon. - Automatic centerline extraction combining with easy selection UI to help fast path setup. - Tagged-stool overlay on endoluminal and band view to enable to handle CT images with minimal preparations. - Batch capture for reconstructed images related to lesions during the exam to report and send to clinicians.

INFINITT Cardiology PACS™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

INFINITT Cardiology PACS is a software device that consists of INFINITT Server (included Database), and INFINITT Cardiology PACS. INFINITT Cardiology PACS is a web-based DICOM view station running on Windows 2000/XP. INFINITT Cardiology PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, QCA and LVA. INFINITT Cardiology PACS allows users to take full advantage of the images from various modalities in order to obtain invaluable mission critical diagnostic data and images. INFINITT supported modalities include: XA, Ultrasound/Echo, MRI, CT and CR/DR. In case of XA and Ultrasound, it offers numerous cardio-specific 2D analysis tools. Intuitive user interface and system architecture offer a configurable work list management and customizable display protocols. Web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update. INFINITT Cardiology PACS supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

Infinitt G3 PACS is a 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 pre-processed 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 an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

INFINITT G3 PACS is a web-based 3D-enabled DICOM viewing station running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. INFINITT G3 PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, Hanging Protocol, 3D segmentation, various MPRs, fast 3D Volume Rendering, MIP, and Virtual Endoscopy. INFINITT G3 PACS 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 G3 PACS, users can have the same diagnostic environment of their own anywhere anytime because INFINITT G3 PACS is deployed through network and supports hanging protocol radically.

Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

Reformat Gateway is a software that receives original data from several devices or PACS system, which reconstructs and sends it to other system automatically. Reformat Gateway reconstructs the thin section slice data into thick section slice data automatically for a fast and routine diagnosis. Also, it generates a MPR reconstructed image automatically according to data specification and distributes original data or reconstructed data to distributed different systems.

StarPACS Dental™ device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

STARPACS Dental™ is a new software application that has been developed to handle digital templates for dental implants, which are placed over digital dental images. The overlay of digital templates onto digital dental images is useful in planning dental implants. The software is used together with the existing STARPACS solution (one of the predicate devices K031013). In addition to imaging and workflow features, STARPACS Dental allows dental implants simulations for dental implanting with the digital template library. STARPACS Dental is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions and possibly to shorten surgery time.