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CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures. When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream. CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.

CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. CADstream receives DICOM magnetic resonance images from a PACS of directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer. Available features support: - . Visualization (standard image viewing tools, MIPs, and reformats) - Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, apparent diffusion coefficient maps, automatic and manual segmentation and 3D volume rendering) - Reporting of user-selected findings and assessment - Interventional planning - Workflow efficiency ■ - 예 Communication and storage (DICOM import/export, query/retrieve, and study storage) The CADstream system consists of proprietary software developed by Merge Healthcare installed on an off-the-shelf computer.

CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures. When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream. CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.

CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. CADstream receives DICOM magnetic resonance images from a PACS or directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer. Available features support: - Visualization (standard image viewing tools, MIPs, and reformats) - Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, and 3D volume rendering) - Reporting of user-selected findings and assessment - Interventional planning - Workflow efficiency - Communication and storage (DICOM import/export, query/retrieve, and study storage) The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf computer.

The Confirma Breast MRI Interventional Components are intended to be used in conjunction with a magnetic resonance scanner and the Confirma Access Breast Coil designs to permit MRI-guided interventional procedures, such as breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

The Confirma Breast MRI Interventional Components provide a grid system to immobilize the breast in an Access Breast Coil device. The grid system allows the physician to perform a biopsy through a needle block inserted in the grid plate. The system supports a standard medial-lateral approach using the Access Breast Coil. The design of the interventional components focuses on ease of patient positioning and set-up by the clinician, and patient ergonomics for enhanced comfort during interventional procedures. The design allows for unilateral or bilateral access, and offers maximum access to aid the physician in MRguided interventional procedures such as breast biopsy and localization of lesions, providing lateral and medial access to the breast. The components are provided non-sterile and are non-disposable. The components must be sterilized at the beginning of each procedure. The components are manufactured from Ultem 1000 polyetherimide which can be autoclaved or sterilized with formaldehyde. The compression plate and grid plate system incorporate locking mechanisms that secure the components once positioned. These locks provide stability during the interventional procedure. The compression and grid plates are bidirectional, allowing them to be placed in either a medial-facing or lateral-facing position. This allows the clinician to perform the interventional procedure from the medial or lateral side. For unilateral breast intervention, the system uses one grid plate and one compression plate. For bilateral breast intervention, the system uses 2 grid plates and 2 compression plates. The components are made of medical grade plastic materials, which are fire rated and have high impact and tensile strength.

The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.

Access Breast Coil 4/SMS is a 4-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast, and axillary tissue. This device is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access. The design of the Access Breast Coil 4/SMS focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of diagnostic and interventional breast MR1 studies. The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in localization of lesions during interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Access is a 7-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast and axillary tissue. Access is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access. The design of the Access breast coil focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of breast MRI studies and interventional procedures. The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast. Features of the Access Breast Coil: Imaging - 7-channel phased array design uses multiple elements that surround . the breast tissue - t Optimized for parallel imaging applications - Supports both unilateral and bilateral imaging exams . - Compatible with Siemens 1.5T MRI systems . - 40 cm field of view . - Extensive coverage of chest wall and axilla ● - High SNR t Ergonomics - Large apertures to accommodate a major percentage of patient . population - Ergonomically designed for patient comfort to minimize motion . artifact Interventional Access - Coil design allows lateral, medial and cranial-caudal interventional . access - Lighting is integrated into the coil for interventional procedures . that demand a well lit area - Compatible with SureLoc software to support interventional MRI .

CADstream is a computer aided detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and provides quantitative measurements of morphological features of the segmented tissues. CADstream performs other user-defined post-processing functions (image subtractions, multiplanar and oblique reformats, maximum intensity projections, image averaging, removal of cardiac artifact). CADstream also can be used to provide accurate and reproducible measurements of the segmented tissues volumes (volumes of interest (VOI)). These measurements include longest diameter, longest in-plane diameters, volume measurement (reported in cc), ratio of breast volume to VOI, distance of VOI to anatomical landmarks, and 3D renderings of the VOI. The system includes an optional remote image viewer (CADalyst™), optimized for viewing breast MR studies processed by CADstream. CADalyst also displays and telecommunicates images from a number of other medical modalities, including ultrasound and digitized mammographic images, processed data from FDA-cleared third party image processing systems, and FDA-approved systems for computer-aided detection and advanced image processing. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation. CADstream™ includes software to support the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures (SureLoc™). Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. CADstream also includes the option to add annotations based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. CADstream is designed to analyze dynamic breast MRI studies. The CADstream system consists of proprietary software developed by Confirma installed on off-the-shelf personal hardware. The CADstream System consists of the following key components: - A PC Server: a desk-side or rack-mount PC capable of running the . Server software, Client User Interface software, and Study Viewer software - Server software: performs CADstream analysis and processing . - . Client User Interface software: an administrative web page hosted on the Server - Study Viewer software (CADalyst): an Image Viewer component, . optimized for viewing breast MR studies processed by CADstream - . Archive System: a PC with a combination CD/DVD burner and printer To initiate CADstream analysis and processing, images are acquired and pushed to the CADstream system from the MR scanner. CADstream is configured to automatically process the images and create additional series. In this configuration, CADstream forwards the processed and original images to the existing softcopy reading station. CADstream Version 4.0 includes the following software features: - CADstream™, which allows the user to select a study to view, define . settings for CADstream processes, process and export CADstream results, and perform administrative tasks. - CADalyst™ (the study viewer), which allows the user to view . CADstream results, interact with the volumes, curves, and AngioMap overlays, and print and save a CADstream Portfolio. This component can be accessed from a standalone CADstream workstation, a remote computer connected to the same network as the CADstream server, such as a PACS, or a PC. - . CADalyst includes multi-modality viewing capabilities, allowing the user to view ultrasound and digitized mammographic images. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation. - SureLoc™ is a guidance tool that assists the user in calculating target ● coordinates for biopsy, wire localization, or other interventional procedures. - DICOM query/retrieve and print, which allows retrieval of DICOM . data from any DICOM-compliant device that is configured for CADstream query and retrieval.

CADstream™ is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and performs other userdefined post-processing fimage subtractions, multiplanar reformats, maximum intensity projections). CADstream also can be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. including automated determination of volumes of interest (VOI), calculation of the longest diameter in X, Y and Z dimensions, the areas of VOI, the volume measurements of VOI (reported in cc), and 3D renderings of VOI. The system includes an optional remote image viewer (CADalyst™), optimized for viewing breast MR studies processed by CADstream. CADstream™ includes software to support the use of breast interventional coils and MR stereotactic localization devices to perform breast interventional procedures (SureLoc™). Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. CADstream is designed to analyze dynamic breast MRI studies. The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as a CADstream display station. The CADstream System consists of the following key components: - . A PC Server: a desk-side or rack mount PC capable of running the Server software, Client User Interface software, and Study Viewer software - . Server software: performs CADstream analysis and processing - Client User Interface software: an administrative web page hosted on the Server . - Study Viewer software (CADalyst): an optional Image Viewer component. . optimized for viewing breast MR studies processed by CADstream - Archive System: a PC with CD burner and printer . In all cases, images are acquired and pushed to the CADstream system from the MR scanner. CADstream is configured to automatically process the images and create additional series. In this configuration, CADstream forwards the processed and original images to the existing softcopy reading station.

CADstream is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. CADstream can also be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an CADstream display station.

ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.

The ACCENT device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The ACCENT software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. The ACCENT system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an ACCENT display station.