classification Automated Radiological Image Processing Software Manufacturer:

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gudid TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. Manufacturer: Terarecon Inc.

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gudid This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy. Manufacturer: Terarecon Inc.

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gudid The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users. The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes. Manufacturer: Genesis Software Innovations LLC

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gudid The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of thepatient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/ Manufacturer: Genesis Software Innovations LLC

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gudid Rapid Platform plus cleared indications for Rapid version 6.x Manufacturer: Ischemaview, Inc.

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gudid Rapid System Update Manufacturer: Ischemaview, Inc.

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gudid DEEPVESSEL Plaque (DVPlaque, the subject device) is a web-based image analysis application for the purpose of characterizing and quantifying plaque and stenosis in coronary arteries based on previously acquired CCTA DICOM data.DVPlaque applies deep learning neural networks to segment coronary arteries, lumen and vessel walls, which will be reviewed and edited by trained and qualified analysts, if needed. Plaque, stenosis, and vessel measurements are outputted based on the analyst-editable segmentation, utilizing simple rule-based mathematical calculation.DVPlaque provides a visualization of DVPlaque analysis in two reports - Cardisight Overview Report and Plaque Analysis Report. In Cardisight Overview Report, location and CAD-RADS stenosis category of the plaque are visually over-viewed in a simplified 2D model if stenosis and plaque exist. In Plaque Analysis Report, quantitative characteristics of the plaque, including total plaque volume, calcified plaque (CP) volume, non-calcified plaque (NCP) volume, low-density plaque (LDP) volume, and plaque burden (defined as percent plaque volume and calculated as total plaque volume/vessel volume) are outputted both on main vessel branch level and on patient level.Reports of DVPlaque are provided to clinicians to enable them to assess the presence and extent of coronary plaque, aiding in determining treatment paths. These reports are not intended to be the final report used in patient diagnosis and treatment, and should be reviewed with other clinical information.Clinicians may request a re-analysis of the CCTA DICOM data if they do not agree with the report analyses. Manufacturer: Keya Medical Technology Co., Ltd.

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gudid Medical Image Post-processing Software Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.

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gudid Medical Image Post-processing Software Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.

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gudid Medical Image Post-processing Software Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.

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gudid Dental Imaging Software. Manufacturer: DRR DENTAL SE

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gudid Neurophet AQUA Manufacturer: NEUROPHET Inc.

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gudid Neurophet AQUA AD Plus Manufacturer: NEUROPHET Inc.

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gudid Neurophet AQUA Manufacturer: NEUROPHET Inc.

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gudid Neurophet SCALE PET Manufacturer: NEUROPHET Inc.

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gudid AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE Manufacturer: Medipixel

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gudid SwiftMR is a stand-alone medical imaging software solution intended for the acceptance, enhancement, processing, review, analysis, communication, and transfer of all body parts MR images in DICOM format. The software may be used for the enhancement of medical images, such as noise reduction and increased image sharpness for MR images.The device is designed for use by healthcare professionals and is intended to assist clinicians, who remain responsible for making all final patient management decisions. The device is not intended for use on mobile devices.The available field strengths are as follows: 0.25T, 0.31T, 0.4T, 0.55T, 0.6T, 1.5T, and 3.0T. Manufacturer: AIRS Medical Inc.

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gudid SwiftSight-Brain Manufacturer: AIRS Medical Inc.

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gudid aprevo, Digital Segmentation Manufacturer: Carlsmed, Inc.

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gudid Magnetic Resonance (MR) Systems Medical Device Software Manufacturer: Siemens Healthineers AG

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gudid MI View&GO Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo Dynamics Manufacturer: Siemens Healthineers AG

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gudid AI-Rad companion Brain MR Manufacturer: Siemens Healthcare GmbH

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gudid MI View&GO Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo Dynamics Manufacturer: Siemens Healthcare GmbH

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gudid syngo Application Software Manufacturer: Siemens Healthcare GmbH

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gudid syngo.CT Coronary Cockpit Manufacturer: Siemens Healthcare GmbH

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gudid Scenium Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo.MI General Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo.MM Oncology Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid. Manufacturer: ClariPI Inc.

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gudid Spectral Bone Marrow MD Application Container for Smart Subscription Manufacturer: GE Medical Systems, L.L.C.

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gudid Spine Auto Views Medical Device Manufacturer: GE MEDICAL SYSTEMS

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gudid MD EchoPAC Plug-in v206 Manufacturer: GE Vingmed Ultrasound A/S

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gudid MD EchoPAC Software Only v206 Manufacturer: GE Vingmed Ultrasound A/S

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gudid HERA Z30 Diagnostic Ultrasound System Manufacturer: SAMSUNG MEDISON CO., LTD.

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gudid TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. Manufacturer: Terarecon Inc.

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gudid Visage Breast Density Manufacturer: Visage Imaging GmbH

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gudid CEPHX3D Manufacturer: ORCA DENTAL AI LTD

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gudid Lvivo Standalone UI Manufacturer: DIA IMAGING ANALYSIS LTD

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gudid Lvivo Seamless Manufacturer: DIA IMAGING ANALYSIS LTD

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gudid Lvivo Mobile Manufacturer: DIA IMAGING ANALYSIS LTD

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gudid Lvivo Software Application Platform Manufacturer: DIA IMAGING ANALYSIS LTD

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gudid The PVAD IQ software is intended for non-invasive analysis of ultrasound images to detect and measure structures fromcardiac ultrasound of patients 18 years old and above, with a Percutaneous Ventricular Assist Device (PVAD). Such use istypically utilized for clinical decision support by a qualified physician. Manufacturer: ULTRASIGHT LTD

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gudid BriefCase-Quantification is an Automated Radiological Image Processing Software. Manufacturer: AIDOC MEDICAL LTD

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gudid BriefCase-Quantification is an Automated Radiological Image Processing Software. Manufacturer: AIDOC MEDICAL LTD

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gudid BriefCase-Quantification is an Automated Radiological Image Processing Software. Manufacturer: AIDOC MEDICAL LTD

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gudid LOGIQ Fortis R3R4 to R5 SW Upgrade Manufacturer: GE Ultrasound Korea Ltd.

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gudid Caption AI on Vscan Manufacturer: GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC

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gudid AngioWaveNet is indicated for use by qualified physicians or under their supervision to aid in the analysis and interpretation of X-ray coronary angiographic cines. AngioWaveNet is intended for use in adults during X-ray coronary angiographic imaging procedures as a clinically useful complement to the viewing of standard angiographic cines acquired during diagnostic coronary angiography procedures. AngioWaveNet software is intended for use to enhance the visibility of blood vessels, vascular structures, and related anatomical features within angiographic images, which may be clinically useful to the treating physician. Manufacturer: AngioWave Imaging, LLC

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gudid MEDIHUB PROSTATE Manufacturer: JLK, Inc.

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gudid POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE Manufacturer: ORTHOFIX SRL

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gudid Change Healthcare Anatomical AI Manufacturer: Change Healthcare Canada Company

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gudid Viz Subdural+ v1.3 (2026-08-03) Manufacturer: VIZ.AI, INC.

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gudid Viz ICH+ v1.24 (2026-08-03) Manufacturer: VIZ.AI, INC.

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gudid Viz RV/LV v1.6 (2026-08-03) Manufacturer: VIZ.AI, INC.

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gudid SMART PCFD Manufacturer: Disior Oy

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gudid SMART Bun-Yo-Matic Xray Manufacturer: Disior Oy

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gudid SMART Bun-Yo-Matic CT Manufacturer: Disior Oy

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gudid ACUSON Origin Diagnostic Ultrasound System Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid Syngo Carbon Clinicals Manufacturer: Siemens Healthcare GmbH

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gudid Scenium Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo.MI General Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo.MM Oncology Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid AI-Rad Companion Brain MR Manufacturer: Siemens Healthcare GmbH

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gudid MI View&GO Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid Scenium Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo.NM Organ Processing Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid syngo.MI General Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid AI-Rad Companion Brain MR Manufacturer: Siemens Healthcare GmbH

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gudid syngo MBF Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.

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gudid AI-Rad Companion Prostate MR About Box Manufacturer: Siemens Healthcare GmbH

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gudid AI-Rad Companion Prostate MR About Box Manufacturer: Siemens Healthcare GmbH

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gudid Fibertracking Manufacturer: Brainlab SE

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gudid Contouring Manufacturer: Brainlab SE

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gudid Image Fusion Manufacturer: Brainlab SE

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gudid Brainlab Elements Contouring Manufacturer: Brainlab SE

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gudid Brainlab Elements Image Fusion Manufacturer: Brainlab SE

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gudid Brainlab Elements BOLD MRI Mapping Manufacturer: Brainlab SE

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gudid LumiNE US Manufacturer: AugmedIT B.V.

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gudid AVIEW CAC Manufacturer: CORELINE SOFT CO.,LTD.

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gudid AVIEW Manufacturer: CORELINE SOFT CO.,LTD.

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gudid AVIEW CAC Manufacturer: CORELINE SOFT CO.,LTD.

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gudid AVIEW Manufacturer: CORELINE SOFT CO.,LTD.

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gudid Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy.The software provides a range of features, including:- 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP).- 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering.- Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning.- Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices.The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management. Manufacturer: EWOO SOFT Co., Ltd

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gudid Akunah Reflect Planning Software Manufacturer: AKUNAH PTY LTD

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gudid IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely reliedupon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology.IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present. Manufacturer: IB Lab GmbH

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gudid CoLumboX Manufacturer: SMART SOFT HEALTHCARE AD

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gudid CoLumbo Manufacturer: SMART SOFT HEALTHCARE AD

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gudid The brAIn Shoulder Positioning software is a cloud-based application intended for shoulder surgeons. The software does not perform surgical planning but provides tools to assist the surgeon with planning primary anatomic and reverse total shoulder replacement surgeries using FX Shoulder Solutions implants. The software is accessible via a web-based interface, where the user is prompted to upload their patient's shoulder CT-scan (DICOM series) accompanied with their information in a dedicated interface. The software automatically segments (using machine learning) and performs measurements on the scapula and humerus anatomy contained in the DICOM series. These segmentations serve as a foundation for the surgeons manual planning, which is performed using an interactive 3D viewer that allows for soft tissue visualization. The surgeon positions the glenoid and humerus implants manually within this same 3D interface using a dedicated manipulation panel. The changes in shoulder anatomy resultant from the implants are relayed in a post-position interface that displays information related to distalization and lateralization. The software outputs a planning multimodal summary that includes textual information (patient information, pre- and post-op measurements) and visual information (screen captures of the shoulder pre- and post-implantation). Manufacturer: AVATAR MEDICAL

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gudid OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest. Manufacturer: REBRAIN

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gudid OptimMRI is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM). Manufacturer: REBRAIN

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gudid BoneMetrics US Manufacturer: GLEAMER

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gudid inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions. Manufacturer: INHEART

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gudid inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART Models Shaper.inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions. Manufacturer: INHEART

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gudid inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper.inHEART MODELS Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions. Manufacturer: INHEART

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gudid inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices.inHEART MODELS Shaper is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists,radiologists, and technicians) and the users are solely responsible for making all final patient management decisions. Manufacturer: INHEART

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gudid inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices).inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper.inHEART MODELS AI is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions. Manufacturer: INHEART

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gudid BrightHeart View Classifier is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound examinations. Manufacturer: BRIGHTHEART

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FDA Product Code: QIH