Other products from "SUN NUCLEAR CORP."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B01612300000TZ0 12300000TZ 12300000TZ Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 3D SCANNER (TNC)
2 B01612200000MR0 12200000MR 12200000MR Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 ArcCHECK-MR
3 B01611790000Z0 11790000Z 11790000Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 SRS MapCHECK
4 B01611630006Z0 11630006Z 11630006Z Radiation therapy QA device. IWB System, Radiation Therapy, Radionuclide 2 6-12 MV ISORAD Detector, (1.5m Cable)
5 B01611620003Z0 11620003Z 11620003Z Radiation therapy QA device. IWB System, Radiation Therapy, Radionuclide 2 1-4 MV ISORAD Detector (3m Cable)
6 B01611620002Z0 11620002Z 11620002Z Radiation therapy QA device. IWB System, Radiation Therapy, Radionuclide 2 1-4 MV ISORAD Detector (3m Cable)
7 B0161122AZ0 1122AZ 1122AZ Accessory to the 1177 MapCHECK2. IYE Accelerator, Linear, Medical 2 Adaptor Plate for GMF
8 B01611130006Z0 11130006Z 11130006Z Radiation therapy QA device. LNH System, Nuclear Magnetic Resonance Imaging 2 Skin QED Detector (1.5m Cable)
9 B01610470001Z0 10470001Z 10470001Z Radiation therapy QA device. LHN System, Radiation Therapy, Charged-Particle, Medical 2 SNC600c (TNC)
10 B01610410001Z0 10410001Z 10410001Z Radiation therapy QA device. LHN System, Radiation Therapy, Charged-Particle, Medical 2 SNC125c Scanning Ionization Chamber (TNC)
11 05060608880928 1230000-4Z 1230000-4Z Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio. IYE Accelerator, Linear, Medical 2 3D TPR
12 05060608880751 1122800Z 1122000-0Z Radiation therapy QA device. LHO Instrument, Quality-Assurance, Radiologic 1 IC PROFILER
13 05060608880669 1122655Z 1122655Z Accessory to the Model 1122 IC PROFILER. Used for photon energy measurements. LHO Instrument, Quality-Assurance, Radiologic 1 Photon Quad Wedge Plate
14 05060608880607 1122-AZ 1122-AZ Accessory to the 1177 MapCHECK2. IYE Accelerator, Linear, Medical 2 Adaptor Plate for GMF
15 05060608880355 12200000MR 12200000MR Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 ArcCHECK-MR
16 05060608880553 11630003Z 11630003Z Radiation therapy QA device IWB System, Radiation Therapy, Radionuclide 2 ISORAD Detector, 6-12MV (+) 3m
17 05060608880362 1231900Z 1231900Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 3D SCANNER (TNC)
18 05060608880300 1230680Z 1230000-4Z Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio IYE Accelerator, Linear, Medical 2 3D TPR
19 05060608880249 1047400Z 1047000-1Z Radiation therapy QA device. LHN System, Radiation Therapy, Charged-Particle, Medical 2 SNC600c (TNC)
20 05060608880195 1231405Z 1231405Z The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an ele The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system. IYE Accelerator, Linear, Medical 2 Halcyon Bracket
21 05060608880188 1179300Z 1179000-0Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 SRS MapCHECK
22 05060608880034 1093300Z 1093000-0Z Radiation therapy QA device. LHO Instrument, Quality-Assurance, Radiologic 1 Daily QA 3
23 B016121600000 12160000 12160000 Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 PlanIQ
24 B01611370000Z0 11370000Z 11370000Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 IVD 2
25 B01611180000Z0 11180000Z 11180000Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 EDGE Dosimetry Detector (BNC)
26 B016108300010 10830001 10830001 Accessory to Model 1177 MapCHECK 2. IXG Phantom, Anthropomorphic, Radiographic 1 MapPHAN (10cm)
27 B01610460001Z0 10460001Z 10460001Z Radiation therapy QA device. LHO Instrument, Quality-Assurance, Radiologic 1 REFERENCE DETECTOR (TNC)
28 05060608880911 1257000-0MR 1257000-0MR Radiation therapy, machine QA device IXG Phantom, Anthropomorphic, Radiographic 1 MultiMet-WL QA
29 05060608880874 1216028 1216028 Radiation therapy QA software. IYE Accelerator, Linear, Medical 2 PlanIQ
30 05060608880591 11640006Z 11640006Z Radiation therapy QA device IWB System, Radiation Therapy, Radionuclide 2 ISORAD Detector, 15-25MV (-) 1.5m
31 05060608880508 11160003Z 11160003Z Radiation therapy QA device LNH System, Nuclear Magnetic Resonance Imaging 2 QED Detector, 15-25MV (+) 3m
32 05060608880447 11140002Z 11140002Z Radiation therapy QA device LNH System, Nuclear Magnetic Resonance Imaging 2 QED Detector, 1-4MV (-) 3m
33 05060608880423 11130003Z 11130003Z Radiation therapy QA device LNH System, Nuclear Magnetic Resonance Imaging 2 QED Detector, Skin (+) 3m
34 05060608880294 1046400Z 1046000-1Z Radiation therapy QA device. LHO Instrument, Quality-Assurance, Radiologic 1 REFERENCE DETECTOR (TNC)
35 05060608880225 1041700Z 1041000-1Z Radiation therapy QA device. LHN System, Radiation Therapy, Charged-Particle, Medical 2 SNC125c (TNC)
36 05060608880058 1137000-0Z 1137000-0Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 IVD 2
37 05060608880119 1041600Z 1041000-0Z Radiation therapy QA device. LHN System, Radiation Therapy, Charged-Particle, Medical 2 SNC125c (BNC)
38 B0161220200Z0 1220200Z 1220200Z Accessory to Model 1220 ArcCHECK. IYE Accelerator, Linear, Medical 2 ArcCHECK Trolley
39 B01612200003Z0 12200003Z 12200003Z Accessory to Models 1220 ArcCHECK and 1220-MR ArcCHECK-MR. LHO Instrument, Quality-Assurance, Radiologic 1 ArcCHECK PMMA MultiPlug
40 B0161177000SZ0 1177000SZ 1177000SZ Accessory to the 1177 MapCHECK2. IYE Accelerator, Linear, Medical 2 Siemens IMF (Isocentric Mounting Fixture)
41 B01611770000Z0 11770000Z 11770000Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 MapCHECK2
42 B01611360000Z0 11360000Z 11360000Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 rf-IVD 2
43 B01611180001Z0 11180001Z 11180001Z Radiation therapy QA device. IYE Accelerator, Linear, Medical 2 EDGE Dosimetry Detector (TNC)
44 B01611150006Z0 11150006Z 11150006Z Radiation therapy QA device. LNH System, Nuclear Magnetic Resonance Imaging 2 6-12MV QED Detector (1.5m Cable)
45 B01611130003Z0 11130003Z 11130003Z Radiation therapy QA device. LNH System, Nuclear Magnetic Resonance Imaging 2 Skin QED Detector (3m Cable)
46 B01611130002Z0 11130002Z 11130002Z Radiation therapy QA device. LNH System, Nuclear Magnetic Resonance Imaging 2 Skin QED Detector (3m Cable)
47 B01610410000Z0 10410000Z 10410000Z Radiation therapy QA device. LHN System, Radiation Therapy, Charged-Particle, Medical 2 SNC125c Scanning Ionization Chamber (BNC)
48 05060608880645 1177000-SZ 1177000-SZ Accessory to the 1177 MapCHECK2. IYE Accelerator, Linear, Medical 2 Siemens IMF (Isocentric Mounting Fixture)
49 05060608880584 11640003Z 11640003Z Radiation therapy QA device IWB System, Radiation Therapy, Radionuclide 2 ISORAD Detector, 15-25MV (+) 3m
50 05060608880522 11620002Z 11620002Z Radiation therapy QA device IWB System, Radiation Therapy, Radionuclide 2 ISORAD Detector, 1-4MV (-) 3m
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10 00195278010797 SIGNA Premier SIGNA Premier System Medical Device Assembly, MDR NA GENERAL ELECTRIC COMPANY
11 00195278005502 SIGNA Pioneer SIGNA Pioneer System Medical Device Assembly - MDR NA GENERAL ELECTRIC COMPANY
12 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.
13 B669SMNS00011 SMNS0001 SMNS0001 MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system. MRIaudio Siemens System MRIAUDIO, INC.
14 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.
15 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.
16 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.
17 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.
18 B6693020 302 302 Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. MRIaudio Ear-Tip MRIAUDIO, INC.
19 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.
20 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.
21 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.
22 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.
23 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.
24 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.
25 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.
26 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.
27 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.
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 B545032000000 03-2000-00 MRopen 0.5 T ASG SUPERCONDUCTORS SPA
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42 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.
43 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.
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47 B237ZXLASB050 ZXL-ASB-05 Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM Zephyr Patient Positioning and Transfer System DIACOR, INC.
48 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.
49 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.
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