Other products from "NORDICNEUROLAB AS"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07090042052061 CRI-1.0 Control Room Interface (CRI) is part of Visual System HD.CRI is the interface un Control Room Interface (CRI) is part of Visual System HD.CRI is the interface unit for video signal in (HDMI) and eye tracking video out (HDMI).The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays, Visual System HD. LNH System, Nuclear Magnetic Resonance Imaging 2 Control Room Interface
2 07090042052092 VPS-1.1 Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HDShielded e Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HDShielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays. LNH System, Nuclear Magnetic Resonance Imaging 2 Visual System Power Supply
3 07090042051064 LCD 3.1 NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, state-of-the-art solution designed specifically for use in the MR environment.LCD 40 is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor.LCD 40 is a 40 inch LCD (Liquid Crystal Display) monitor, compatible with MR system up to 3T.The LCD monitor uses standard HDMI display signal, and can be connected to any computer or video output device with digital outputs.The LCD monitor are capable to show video signals in 4K UHD format (3840x2160 pixels)The LCD monitor is equipped with an integrated VGA camera. LNH System, Nuclear Magnetic Resonance Imaging 2 Inroom Viewing Device
4 07090042054058 SB- 3.2 SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directl SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directly to the MRI scanner where it receives timing pulses sent out with each image series and demodulates this signal before it’s forwarded to the stimulus PC. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings. LNH System, Nuclear Magnetic Resonance Imaging 2 SyncBox
5 07090042054034 SB 3.0 SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directl SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directly to the MRI scanner where it receives timing pulses sent out with each image series and demodulates this signal before it’s forwarded to the stimulus PC. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings. LNH System, Nuclear Magnetic Resonance Imaging 2 SyncBox
6 07090042054010 4.0 The ResponseGrip is an MRI-safe patient response device, providing real-time fee The ResponseGrip is an MRI-safe patient response device, providing real-time feedback of a patient response. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces. LNH System, Nuclear Magnetic Resonance Imaging 2 ResponseGrips
7 07090042055017 FLT 2.1 Fiberlink transmitter is part of NordicNeuroLab’s fMRI System.Fiberlink transmit Fiberlink transmitter is part of NordicNeuroLab’s fMRI System.Fiberlink transmitter converts audio and video signals into an optical signal for transmission.Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System. LNH System, Nuclear Magnetic Resonance Imaging 2 Fiberlink transmitter
8 07090042054041 RGI-2.2 ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Re ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PCThe ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces. LNH System, Nuclear Magnetic Resonance Imaging 2 ResponseGrip Interface
9 07090042054027 2.0 ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Re ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PCThe ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces. LNH System, Nuclear Magnetic Resonance Imaging 2 ResponseGrip Interface
10 07090042053020 HPS 1.0 Head Phones Slim is part of NordicNeuroLab’s Audio System.The AudioSystem allows Head Phones Slim is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T. LNH System, Nuclear Magnetic Resonance Imaging 2 HeadPhones Slim
11 07090042051057 LPS-3.1 LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD MonitorShielded enclosur LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD MonitorShielded enclosure containing the Power Supply Unit for the LCD Monitor which is located in the MR environment. LPS is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor. LNH System, Nuclear Magnetic Resonance Imaging 2 LCD Power Supply
12 07090042051040 LPS 3.0 LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD MonitorShielded enclosur LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD MonitorShielded enclosure containing the Power Supply Unit for the LCD Monitor which is located in the MR environment. LPS is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor. LNH System, Nuclear Magnetic Resonance Imaging 2 LCD Power Supply
13 07090042059046 1.1 LLZ System, Image Processing, Radiological 2 nordicDSC
14 07090042052085 VHD-1.1 The VisualSystem HD allows video signals from the stimulus presentation PC to en The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays (Visual System HD) LNH System, Nuclear Magnetic Resonance Imaging 2 Visual System HD
15 07090042052108 VHD-1.2 The VisualSystem HD allows video signals from the stimulus presentation PC to en The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays (Visual System HD) LNH System, Nuclear Magnetic Resonance Imaging 2 Visual System HD
16 07090042052023 ETC 2.0 LNH System, Nuclear Magnetic Resonance Imaging 2 Eye Tracker Camera
17 07090042059022 1.3 NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software w NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient. LNH System, Nuclear Magnetic Resonance Imaging 2 nordicAktiva
18 07090042059015 2.3 The nordicBrainEx Software is a post-processing application for dynamic MRI data The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focuson ease of use and high performance on a standard Windows workstation. The software providescomprehensive functionality for dynamic image analysis and visualization of MRI data, where signalchanges over time are analyzed to determine various modality dependent functional parameters. Thefollowing algorithms provide the main functional analyses of the application.- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in thehuman brain in areas with altered blood-flow resulting from neuronal activity.- DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis ofdiffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusionto display the white matter structure in the brain.- DSC: Calculations of perfusion related parameters that provide information about the bloodvessel structure and characteristics. Examples of such maps are blood volume, blood flow, timeto peak, mean transit time and leakage.In addition to these specific functional analyses, the application also provides general visualization tools,a database for data handling, and a reporting feature. This is to ensure that the workflow of theapplication is optimized to ensure efficiency and high throughput in a clinical environment. LLZ System, Image Processing, Radiological 2 nordicBrainEx
19 07090042055024 SIU 2.0 Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System.SIU is a s Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System.SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System.SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system LNH System, Nuclear Magnetic Resonance Imaging 2 Shielded Interface Unit
20 07090042053044 CC 2.3 CommunicationConsole is part of NordicNeuroLab’s Audio System.The AudioSystem al CommunicationConsole is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. LNH System, Nuclear Magnetic Resonance Imaging 2 CommunicationConsole
21 07090042052078 1.1 The VisualSystem HD allows video signals from the stimulus presentation PC to en The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays (Visual System HD)The VisualSystem Power Cable (VPC) provides connection between the VisualSystem Power Supply (VPS) And the coil mounted displays (VHD) LNH System, Nuclear Magnetic Resonance Imaging 2 VisualSystem Power Cable (VPC)
22 07090042053013 HP 1.3 Head Phones is part of NordicNeuroLab’s Audio System.The AudioSystem allows audi Head Phones is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.The Head Phone is designed specifically for use in the MR environment, and are compatible with MR system up to 3T. LNH System, Nuclear Magnetic Resonance Imaging 2 Headphones
23 07090042052016 CMD 2.3 Coil Mounted Display is part of NordicNeuroLab’s VisualSystem. The VisualSystem Coil Mounted Display is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor.Coil Mounted Display is a flexible solution for presenting visual stimuli inside the MR scanner, which is based on OLED technology. LNH System, Nuclear Magnetic Resonance Imaging 2 Coil Mounted Display
Other products with the same Product Code "LNH"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B672MYOSTRAIN050102 5.1.2 MyoStrain software is an image processing device that post-processes strain-enco MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements MyoStrain MYOCARDIAL SOLUTIONS, INC.
2 B669SMNS00011 SMNS0001 SMNS0001 MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system. MRIaudio Siemens System MRIAUDIO, INC.
3 B66935011 3501 3501 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solu The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection. MRIaudioPREM1001 with MRIview MRIAUDIO, INC.
4 B66935001 3500 3500 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solu The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection. MRIaudioPREM1000 with MRIview MRIAUDIO, INC.
5 B6693301 330 330 MRI-safe ear defenders provide patients with 29dB of hearing protection and allo MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection. MRIaudio Over-Ear Headphones MRIAUDIO, INC.
6 B6693201 320 320 MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB hearing protection and allows patients to listen to audio entertainment. Standard two prong pneumatic headphone connection. Designed for use with MRIaudio Ear-tips. Wishbone Headset MRIAUDIO, INC.
7 B6693020 302 302 Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. MRIaudio Ear-Tip MRIAUDIO, INC.
8 B66930001 3000 3000 The MRIview is an MRI conditional video solution that provides MRI patients with The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment. MRIview MRIAUDIO, INC.
9 B66916001 1600 1600 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1600 MRIAUDIO, INC.
10 B66915061 1506 1506 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1506 MRIAUDIO, INC.
11 B66915051 1505 1505 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1505 MRIAUDIO, INC.
12 B66914001 1400 1400 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1400 MRIAUDIO, INC.
13 B6691011 101 101 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing. 3G Transducer MRIAUDIO, INC.
14 B66910021 1002 1002 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudioPREM1002 MRIAUDIO, INC.
15 B66910011 1001 1001 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudioPREM1001 MRIAUDIO, INC.
16 B66910001 1000 1000 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudioPREM1000 MRIAUDIO, INC.
17 B554MRCP1000 1.0 MRCP+v1 is indicated for use as a software-based image processing system for non MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment.MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols.MRCP+v1 is suitable for all patients not contra-indicated for MRI. MRCP+ PERSPECTUM LTD
18 B554LMS5000 5.0.0 LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnosti LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
19 B554LMS4000 4.0.0 LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may optionally be computed using the DIXON or LMS MOST methodologies. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
20 B554LMS3500 3.5.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
21 B554LMS3400 3.4.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
22 B554LMS3300 3.3.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
23 B554LMS3200 3.2.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
24 B554LMS3100 3.1.0 LiverMultiScan (LMSv3) is a standalone software device. The purpose of the Liver LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). The LiverMultiScan (LMSv3) is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is then sent to an interpreting clinician.The interpreting clinician needs to take into consideration the device’s limitations and accuracy during clinical interpretation.LiverMultiScan (LMSv3) is not intended to replace the established procedures for the assessment of a patients liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.The device is intended to be used by a trained operator to generate metrics for subsequent interpretation by a clinician.The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan (LMSv3) metrics. The purpose of a LiverMultiScan (LMSv3) metrics is to provide imaging information to assist in characterizing tissue in the liver, which are additional to existing methods for obtaining information relating to the liver. LiverMultiScan (LMSv3) metrics are not intended to replace any existing diagnostic source of information, but can be used to identify patients who LiverMultiScan PERSPECTUM LTD
25 B554LMS2100 2.1 LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan PERSPECTUM LTD
26 B554LMS2000 2.0 LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan PERSPECTUM LTD
27 B554HEPATICA100 1.0.0 Hepatica (Hepatica v1) is a post-processing medical device software that present Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making. Hepatica PERSPECTUM LTD
28 B545032000000 03-2000-00 MRopen 0.5 T ASG SUPERCONDUCTORS SPA
29 B440HVCP030 030004 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
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31 B358PCI01PP0 4.1 PCI01PP Prism Process® software is used in conjunction with a Magnetic Resonance scanner Prism Process® software is used in conjunction with a Magnetic Resonance scanner to process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI), and other MRI data sets. Prism Process performs post-processing for quality control and subsequent viewing of fMRI and other data. Prism Process PRISM CLINICAL IMAGING, INC.
32 B358PCI01PA0 4.1 PCI01PA Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned for fMRI. The patient’s responses and image data from the MRI scanner are stored for use by Prism Process. Prism Acquire PRISM CLINICAL IMAGING, INC.
33 B237ZXLASR110 ZXL-ASR-11 GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp Zephyr Patient Positioning and Transfer System DIACOR, INC.
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35 B237ZXLASB060 ZXL-ASB-06 Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems Zephyr Patient Positioning and Transfer System DIACOR, INC.
36 B237ZXLASB050 ZXL-ASB-05 Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM Zephyr Patient Positioning and Transfer System DIACOR, INC.
37 B237ZXLADK510 ZXL-ADK-51 Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) foot end stop Zephyr Patient Positioning and Transfer System DIACOR, INC.
38 B237ZXLADK500 ZXL-ADK-50 Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar a Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit for MR couch Zephyr Patient Positioning and Transfer System DIACOR, INC.
39 B237ZXLADK100 ZXL-ADK-10 Zephyr Docking Kit 50cm for GE PET/MR Flat Table Top (FTT) Zephyr Patient Positioning and Transfer System DIACOR, INC.
40 B237ZXLACI140 ZXL-ACI-14 Zephyr IR-S Collision Indicators for GE GEM MR Cart Zephyr Patient Positioning and Transfer System DIACOR, INC.
41 B237ZXLACI130 ZXL-ACI-13 Zephyr IR-S Collision Indicators for GE Premier Fixed Couch Zephyr Patient Positioning and Transfer System DIACOR, INC.
42 B237ZXLACI120 ZXL-ACI-12 Zephyr IR-A Collision Indicators for GE MOTUS MR Cart Zephyr Patient Positioning and Transfer System DIACOR, INC.
43 B237ZXLACI110 ZXL-ACI-11 Zephyr IR-A Collision Indicators for GE GEM MR Cart Zephyr Patient Positioning and Transfer System DIACOR, INC.
44 B237ZXLACI100 ZXL-ACI-10 Zephyr IR-S Collision Indicators for Philips Ingenia MR-RT System Zephyr Patient Positioning and Transfer System DIACOR, INC.
45 B237ZXLABP100 ZXL-APB-10 Zephyr HP Accessory - Baseplate for S-Style thermoplastic masks Zephyr Patient Positioning and Transfer System DIACOR, INC.
46 B01611160006Z0 11160006Z 11160006Z Radiation therapy QA device. 15-25 MV QED Detector (1.5m Cable) SUN NUCLEAR CORP.
47 B01611160003Z0 11160003Z 11160003Z Radiation therapy QA device. 15-25MV QED Detector (3m Cable) SUN NUCLEAR CORP.
48 B01611160002Z0 11160002Z 11160002Z Radiation therapy QA device. 15-25MV QED Detector (3m Cable) SUN NUCLEAR CORP.
49 B01611150006Z0 11150006Z 11150006Z Radiation therapy QA device. 6-12MV QED Detector (1.5m Cable) SUN NUCLEAR CORP.
50 B01611150003Z0 11150003Z 11150003Z Radiation therapy QA device. 6-12MV QED Detector (3m Cable) SUN NUCLEAR CORP.