classification System, Image Processing, Radiological Manufacturer:

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gudid IBM iConnect Access Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Merge Unity PACS Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Merge OrthoPACS Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Stand alone software application. Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Merge PACS Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Merge Unity Pacs Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Merge OrthoPACS Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Merge PACS Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application. Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid Standalone software application Manufacturer: MERGE HEALTHCARE SOLUTIONS INC.

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gudid DEXIS 10 (DEXIS Imaging Suite) Manufacturer: Dental Imaging Technologies Corporation

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gudid MICROSOFT SurfacePro7 - Planner/Verifier Manufacturer: Medacta International SA

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gudid Advanced MyHip Planner Manufacturer: Medacta International SA

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gudid WebPlanner Spine Software Manufacturer: Medacta International SA

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gudid MyPlanner Spine Manufacturer: Medacta International SA

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gudid StorM-Base 2.0 Manufacturer: Storz Medical AG

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gudid A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device. Manufacturer: MASTERLINK LLC

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gudid Dental imaging capture, enhance and display software. Manufacturer: MASTERLINK LLC

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gudid Curve Image is a cloud-based dental image acquisition and management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer. Manufacturer: Curve Dental

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gudid Curve Dental develops and markets a cloud-based dental practice management system titled Curve Hero. Using a Mac or PC platform, a dental practice can use Curve Hero to manage all aspects of their practice, from scheduling to charting to billing, or from front desk to operatory. The application provides for secure and redundant management of all patient records and patient communications. Additionally, when utilizing Curve Dentals Curve Image, the practice can also capture digital images directly to the cloud. Manufacturer: Curve Dental

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gudid Dental surgery treatment planning software Manufacturer: Dental Wings GmbH

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gudid Dental implant planning software Manufacturer: Dental Wings GmbH

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gudid End Users of the PRE-SURE device receive digital and/or physical patient anatomical models from Lazarus 3D. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications. Digital models may be viewed by End Users using any program cleared for their intended use. The PRE-SURE patient modeling system is a method for the creation of patient models. This system will be used exclusively by Lazarus 3D, with some physician input and feedback, to produce models for End Users. Importantly, and unlike other 3D modeling systems, in the PRE-SURE process the design and production of patient models is performed by Lazarus 3D and not by the End User or a third party. The internal process within Lazarus 3D used for creating PRE-SURE patient models includes use of an FDA cleared stand-alone software package. As a part of the PRE-SURE production process, this software is intended for internal use within Lazarus 3D to create digital anatomical models from patient radiological data that can be used by End Users for a variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printing-based production process performed by Lazarus 3D to create physical patient models. Each individual patients model can be created rapidly from the patients radiological data using Lazarus 3Ds patented rapid prototyping technology. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed. Manufacturer: Lazarus 3d, Inc.

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gudid AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: Manual annotation tools for users to select regions of interest (ROIs), Semi-automatic lesion segmentation suggestions for user-selected ROIs, Automatic measurement and display of long and short axis of segmented lesions, Automatic tabulation and summation of measurements, Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report. Manufacturer: Ai Metrics, LLC

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gudid The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.On mobile platforms, this device is not intended for diagnostic use. Manufacturer: Hyland Software Canada ULC

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gudid Nical Flat Panel Manufacturer: NICAL SPA

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gudid MediMatic Manufacturer: MEDIMATIC SRL

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid Caas Qardia Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid Caas Qardia Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Qardia Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Qardia Manufacturer: Pie Medical Imaging B.V.

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gudid Text to be remove Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS A-Valve Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MR Solution Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid Development ongoing Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS IntraVascular Manufacturer: Pie Medical Imaging B.V.

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gudid Development ongoing Manufacturer: Pie Medical Imaging B.V.

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gudid Development ongoing Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MR Solutions Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS IntraVascular Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MR 4D Flow Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MRV Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MR 4D Flow Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MRV Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid 3mensio Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS Workstation Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS IntraVascular Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MR Flow Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS MRV Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS A-Valve Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS A-Valve Manufacturer: Pie Medical Imaging B.V.

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gudid CAAS 5 Manufacturer: Pie Medical Imaging B.V.

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gudid Prosthesis modelling (stand-alone) Manufacturer: 3DIEMME SRL

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gudid 3D diagnosis and communication module Manufacturer: 3DIEMME SRL

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gudid Surgical guides modelling Manufacturer: 3DIEMME SRL

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gudid Implants planning Manufacturer: 3DIEMME SRL

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gudid Mobile version Manufacturer: 3DIEMME SRL

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gudid Neowise is a medical imaging software intended for use in dental and medical applications as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. Manufacturer: CEFLA SOCIETA' COOPERATIVA

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gudid Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. Itcontrols exam retrieval, display, enhancement, and saving of digital images from various digital imagingsystems. It stores and communicates these images within the system or across computer systems atdistributed locations. Manufacturer: DE GTZEN SRL

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gudid Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. Itcontrols exam retrieval, display, enhancement, and saving of digital images from various digital imagingsystems. It stores and communicates these images within the system or across computer systems atdistributed locations. It is distributed on DVD Manufacturer: DE GTZEN SRL

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gudid Zirkonzahn.Implant-Planner Practice incl. Bone & Tooth Segmentation module - LicenseThe conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months! Manufacturer: ZIRKONZAHN SRL

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gudid Zirkonzahn.Implant-Planner incl. Bone & Tooth Segmentation module - LicenseThe conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months! Manufacturer: ZIRKONZAHN SRL

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gudid Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months!Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice Manufacturer: ZIRKONZAHN SRL

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gudid Rights of use Zirkonzahn.Implant-Planner The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for the duration of 12 months!Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Manufacturer: ZIRKONZAHN SRL

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gudid ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. Manufacturer: IMMERSIVETOUCH, INC.

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gudid ImmersiveTouch is a stand-alone modular software package that allows users to import, visualize, and segment medical images to create accurate 3D representations. Manufacturer: IMMERSIVETOUCH, INC.

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gudid The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. Manufacturer: IMMERSIVETOUCH, INC.

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gudid Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors.Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists.When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use. Manufacturer: IMMERSIVETOUCH, INC.

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FDA Product Code: LLZ