Other products from "DEERFIELD IMAGING, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857534006547 InSitu Coil, Open, 1.5T Large 120018-000 InSitu Coil, Open, 1.5T Large 120018-000 MOS Coil, Magnetic Resonance, Specialty 2 InSitu Coil
2 00857534006745 120823-000 IMRIS IMRI 3T V LNH,LNI,MOS System, Nuclear Magnetic Resonance Imaging,System, Nuclear Magnetic Resonance Sp System, Nuclear Magnetic Resonance Imaging,System, Nuclear Magnetic Resonance Spectroscopic,Coil, Magnetic Resonance, Specialty 2 IMRIS iMRI 3T V
3 00857534006554 InSitu Coil, Open, 3T Large 120019-000 InSitu Coil, Open, 3T Large, 120019-000 MOS Coil, Magnetic Resonance, Specialty 2 InSitu Coil
4 00857534006448 HC150 Lower Coil LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-600 MOS Coil, Magnetic Resonance, Specialty 2 HC150 - 1.5T Head Coil Lower
5 00857534006134 HC150 Lower Coil LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000 MOS Coil, Magnetic Resonance, Specialty 2 HC150 - 1.5T Head Coil Lower
6 00857534006004 HFD210 MR/X-ray Head Fixation Device (HFD210),112634-000 HBL Holder, Head, Neurosurgical (Skull Clamp) 2 MR/X-ray HFD (HFD 210)
7 00857534006561 MR Neuro Accessory Adaptor ORT 400 table MR Neuro Accessory Adaptor- 120025-000 GDC,KXJ Table, Operating-Room, Electrical,Table, Radiologic 1 ORT 400 (Trumpf TruSystem 7500 MR Neuro) table
8 00857534006707 119900-003 ORT 400 table, Patient Support Board 119900-003 KXJ,GDC Table, Radiologic,Table, Operating-Room, Electrical 1 Patient Support Board
9 00857534006714 119749-000 ORT 400 table, Patient Support Board with Label 119749-000 KXJ,GDC Table, Radiologic,Table, Operating-Room, Electrical 1 Patient Support Board
10 00857534006424 HC300 Lower Coil Lower Assy, 3T IOH V2, 110840-600 MOS Coil, Magnetic Resonance, Specialty 2 HC300 -3T Head Coil Lower Assy
11 00857534006417 HC300 Upper Assy Upper Assy, 3T IOH V2, 110833-600 MOS Coil, Magnetic Resonance, Specialty 2 HC300- 3T Head Coil Upper Assy
12 00857534006233 HC300 Upper Assy Upper Assy, 3T IOH V2, 110833-000 MOS Coil, Magnetic Resonance, Specialty 2 HC300- 3T Head Coil Upper Assy
13 00857534006226 HC300 Lower Coil Lower Assy, 3T IOH V2, 110840-000 MOS Coil, Magnetic Resonance, Specialty 2 HC300 -3T Head Coil Lower Assy
14 00857534006523 HC150 Lower Coil LOWER COIL ASSEMBLY, 1.5T Neuro II-S, 119980-000 MOS Coil, Magnetic Resonance, Specialty 2 HC150 - 1.5T Head Coil Lower Neuro II-S
15 00857534006219 iCT System iCT System 115219-000 JAK System, X-Ray, Tomography, Computed 2 iCT
16 00857534006028 HFD 200 MR/X-ray Head Fixation Device (HFD200), 113010-000 HBL Holder, Head, Neurosurgical (Skull Clamp) 2 MR/X-ray HFD (HFD 200)
17 00857534006486 ORT100 T2X OR Table V.2, 110470-600 FQO,KXJ Table, Operating-Room, Ac-Powered,Table, Radiologic 1 ORT100 Table
18 00857534006394 HFD100 Head Fixation Device HFD100 , 113803-600 HBL Holder, Head, Neurosurgical (Skull Clamp) 2 Head Fixation Device HFD100
19 00857534006370 InSitu Coil, Open 3T InSitu Coil, Open, 3T Large, Pouched, 114893-001 MOS Coil, Magnetic Resonance, Specialty 2 InSitu Coil, 3T
20 00857534006332 ORT100 T2X OR Table V.2, 110470-000 KXJ,FQO Table, Radiologic,Table, Operating-Room, Ac-Powered 1 ORT100 Table
21 00857534006189 iMRX System AR-DR MR30RS iMRX System AR-DR MR30RS,105824-000 IZI,LNH System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging 2 iMRX System
22 00857534006165 iMRX System AR-DR-OR iMRX System AR-DR-OR, MR30R, 105828-000 LNH,IZI System, Nuclear Magnetic Resonance Imaging,System, X-Ray, Angiographic 2 iMRX System
23 00857534006158 Post Assy, 1.5T 16CH Cardiac Coil iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000 IZI,LNH System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging 2 iMRX System
24 00857534006141 ANTERIOR ASSY, 3T 16CH CARDIAC COIL iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000 IZI,LNH System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging 2 iMRX System
25 00857534006127 POSTERIOR ASSY, 3T 16CH CARDIAC COIL iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000 IZI,LNH System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging 2 iMRX System
26 00857534006110 Ant Assy, 1.5T 16CH Cardiac Coil iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000 IZI,LNH System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging 2 iMRX System
27 00857534006066 OR-DR 116119-000 IMRIS SSK OR-DR Full Body Imaging, 116119-000 LNH System, Nuclear Magnetic Resonance Imaging 2 iMRI 3T S
28 00857534006059 OR-DR, 116118-000 IMRIS SSK OR-DR Partial Body Imaging, 116118-000 LNH System, Nuclear Magnetic Resonance Imaging 2 iMRI 3T S
29 00857534006042 OR-DR-OR 116117-000 IMRIS SSK OR-DR-OR Full Body Imaging,116117-000 LNH System, Nuclear Magnetic Resonance Imaging 2 iMRI 3T S
30 00857534006035 OR-DR-OR 116053-000 IMRIS SSK OR-DR-OR Partial Body Imaging, 116053-000 LNH System, Nuclear Magnetic Resonance Imaging 2 iMRI 3T S
31 00857534006011 HFD100 Head Fixation Device HFD100 , 113803-000 HBL Holder, Head, Neurosurgical (Skull Clamp) 2 Head Fixation Device HFD100
32 00857534006646 Application Platform 4.0 KIT Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000 LMD System, Digital Image Communications, Radiological 1 VISIUSmatrix
33 00857534006264 HFD100 Rocker Arm Accessory Rocker Arm Accessory Kit HFD100, 117948-000 HBL Holder, Head, Neurosurgical (Skull Clamp) 2 HFD100 Rocker Arm Accessory
34 00857534006622 Application Platform 4.0- 3 Room Applications Platform 4.0 US/JPN – 3 Room- 119897-000 LMD System, Digital Image Communications, Radiological 1 VISIUSmatrix
35 00857534006431 HC150 Lower Assy Lower Assembly, 1.5T IOHv2 (Es), 110821-600 MOS Coil, Magnetic Resonance, Specialty 2 HC150 - 1.5T Head Coil Lower Assy
36 00857534006516 ORT 400 (Trumpf TruSystem 7500 MR) table ORT 400 (Trumpf TruSystem 7500 MR) table Assembly, 119493-000 KXJ,GDC Table, Radiologic,Table, Operating-Room, Electrical 1 ORT 400 (Trumpf TruSystem 7500 MR) table
37 00857534006509 ORT 400 (Trumpf TruSystem 7500 MR) Control Panel Assy ORT 400 (Trumpf TruSystem 7500 MR) table, Control Panel Assy 119409-000 GDC,KXJ Table, Operating-Room, Electrical,Table, Radiologic 1 ORT 400 (Trumpf TruSystem 7500 MR) table
38 00857534006493 Application Platform 4.0 2-Room Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000 LMD System, Digital Image Communications, Radiological 1 VISIUSmatrix
39 00857534006462 ORT300 ORT300 Modular Table Main Unit Assy, 114093-600 KXJ,FQO Table, Radiologic,Table, Operating-Room, Ac-Powered 1 ORT300 Table
40 00857534006356 ORT300 ORT300 Modular Table Main Unit Assy, 114093-000 FQO,KXJ Table, Operating-Room, Ac-Powered,Table, Radiologic 1 ORT300 Table
41 00857534006325 Horseshoe Headrest HFD200 Assembly Horseshoe Headrest HFD200 Assembly, 116343-00 HBM Headrest, Neurosurgical 1 Horseshoe Headrest
42 00857534006318 Horseshoe Headrest HFD100 Assembly Horseshoe Headrest HFD100 Assembly, 116341-00 HBM Headrest, Neurosurgical 1 Horseshoe Headrest
43 00857534006240 HC150 Lower Assy Lower Assembly, 1.5T IOHv2 (Es), 110821-000 MOS Coil, Magnetic Resonance, Specialty 2 HC150 - 1.5T Head Coil Lower Assy
44 00857534006202 Neuro III-SV iMRI System Neuro III-SV Multi-Room Imaging Suite MR30LS Enhancement OR-DR, 116189-000 LNH System, Nuclear Magnetic Resonance Imaging 2 Neuro III-SV iMRI System
45 00857534006196 Neuro III-SV iMRI System Neuro III-SV Multi-Room Imaging Suite MR30RS Enhancement [OR-DR-OR], 118396-000 LNH System, Nuclear Magnetic Resonance Imaging 2 Neuro III-SV iMRI System
46 00857534006288 VISIUSeye iMRI 1.5T A and 3TS VISIUSeye iMRI 1.5T A and 3TS, 117534-000 FTY Tape, Measuring, Rulers And Calipers 1 VISIUSeye
47 00857534006578 VISIUSeye iMRI 1.5T A and 3TS 120028-000 VISIUSeye iMRI 1.5T A and 3TS, 120028-000 FTY Tape, Measuring, Rulers And Calipers 1 VISIUSeye
48 00857534006639 Application Platform 4.0- KIT Applications Platform 4.0 US/JPN – INT KIT-120085-000 LMD System, Digital Image Communications, Radiological 1 VISIUSmatrix
49 00857534006479 ORT200 ORT200 50/60Hz Covered Table Assy V2, 114148-600 KXJ,FQO Table, Radiologic,Table, Operating-Room, Ac-Powered 1 ORT200 Table
50 00857534006387 InSitu Coil, Open, 1.5T InSitu Coil, Open, 1.5T Large, Pouched,114892-001 MOS Coil, Magnetic Resonance, Specialty InSitu Coil, 1.5T
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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.
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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.
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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.
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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
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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.
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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.
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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.