Other products from "SIEMENS HEALTHCARE GMBH"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04056869014234 07577732 MRI Coil LNI,MOS,LNH System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging 2 Head Matrix MR Coil
2 04056869014012 11060606 JAK System, x-ray, tomography, computed 2 syngo.CT Dental
3 04056869013046 10046734 JAK System, x-ray, tomography, computed 2 Somatom Perspective (DE)
4 04056869013039 10046733 JAK System, x-ray, tomography, computed 2 Somatom Perspective (DE)
5 04056869014104 05512038 MRI Coil LNI,LNH,MOS System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 FLEX SMALL 047 CPL.
6 04056869008844 04809815 JAK System, x-ray, tomography, computed 2 Insert Osteo mat
7 04056869008820 03810962 JAK System, x-ray, tomography, computed 2 Osteo CT P10
8 04056869285801 11582847 LLZ System, image processing, radiological 2 syngo.via
9 04056869267234 11407657 MOS Coil, magnetic resonance, specialty 2 BM Contour L Coil
10 04056869267227 11407658 MOS Coil, magnetic resonance, specialty 2 BM Contour L Coil set 0.55T
11 04056869259802 11461857 syngo.via VB50A Medical Device Identifier LLZ System, image processing, radiological 2 syngo.via
12 04056869247953 11368091 syngo.via VB40A USB Media Virtual Container (Package) LLZ System, image processing, radiological 2 syngo.via
13 04056869237633 11461436 syngo.via VB40A Medical Device Identifier LLZ System, image processing, radiological 2 syngo.via
14 04056869154992 11107444 IZL System, x-ray, mobile 2 MOBILETT Elara Max
15 04056869149325 11327700 JAK,IZI,OWB,JAA System, x-ray, tomography, computed,System, x-ray, angiographic,Interventional f System, x-ray, tomography, computed,System, x-ray, angiographic,Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified 2 ARTIS icono floor
16 04056869123646 11299058 syngo.via VB30 Medical Device Identifier LLZ System, image processing, radiological 2 syngo.via
17 04056869106212 11299040 syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover "HF02": U syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover "HF02": Unit contains following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syng LLZ System, image processing, radiological 2 syngo.via
18 04056869084725 11299019 syngo.via VB20A "Stock Keeping Unit C" - packaging label "HF02": This unit conta syngo.via VB20A "Stock Keeping Unit C" - packaging label "HF02": This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syngo.CT LLZ System, image processing, radiological 2 syngo.via
19 04056869054964 11298722 syngo.via VB20A "Stock Keeping Unit C" - packaging label: This unit contains the syngo.via VB20A "Stock Keeping Unit C" - packaging label: This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syngo.CT Neuro D LLZ System, image processing, radiological 2 syngo.via
20 04056869054957 11298712 syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover: This uni syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)sy LLZ System, image processing, radiological 2 syngo.via
21 04056869053196 10561700 JAK System, x-ray, tomography, computed 2 syngo.CT View&GO
22 04056869044651 11105252 LLZ System, image processing, radiological 2 syngo.Breast Care
23 04056869040134 11298680 syngo.via VB20A product label - about box LLZ System, image processing, radiological 2 syngo.via
24 04056869033686 11298690 syngo.via VA30B "Stock Keeping Unit B" - product label DVD Media Cover: This uni syngo.via VA30B "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1) syngo.via GTIN 04056869020976 (2) syngo.interventional GTIN 04056869020501 (3) syngo.CT Coronary Analysis GTIN 04056869007762(4) syngo.CT Cardiac Function - GTIN 04056869007779 (5) syngo.CT CaScoring - GTIN 04056869007786 (6) syngo.CT Vascular AnalysisGTIN 04056869007793 (7) syngo.CT Colonography - GTIN 04056869007809 (8) syngo.CT Pulmo3D - GTIN 04056869007816 ( LLZ System, image processing, radiological 2 syngo.via
25 04056869033679 11298689 syngo.via VA30B "Stock Keeping Unit C" - packaging label This unit contains the syngo.via VA30B "Stock Keeping Unit C" - packaging label This unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869020976 (2) syngo.interventional - GTIN 04056869020501(3) syngo.CT Coronary Analysis - GTIN 4056869007762 (4) syngo.CTCardiac Function - GTIN 04056869007779 (5) syngo.CT CaScoring - GTIN 04056869007786 (6) syngo.CT Vascular Analysis -- GTIN 04056869007793 (7) syngo.CT Colonography - GTIN 04056869007809 (8) syngo.CT Pulmo3D - GTIN 04056869007816 (9) syng LLZ System, image processing, radiological 2 syngo.via
26 04056869020976 11250093 "syngo.via VA30B product label - about box" LLZ System, image processing, radiological 2 syngo.via
27 04056869023083 10835464 contains Medical Device Mat.: 10835689 (GTIN: 04056869044699) 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 Spine 32 RS coil kit 3T
28 04056869020891 11250065 syngo.via VB10B"Stock Keeping Unit C"- packaging labelThis unit contains the fol syngo.via VB10B"Stock Keeping Unit C"- packaging labelThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9) syngo.CT Neur LLZ System, image processing, radiological 2 syngo.via
29 04056869020884 11250036 syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit c syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9 LLZ System, image processing, radiological 2 syngo.via
30 04056869015484 10835455 Contains Medical Device Mat. 10835446 (GTIN:04056869015460) LNI,LNH,MOS System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 Body 30 MR coil set 3T
31 04056869014883 10496530 MRI Coil LNH,MOS,LNI System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic 2 Body 18 MR Coil 1.5T
32 04056869014777 10185549 Contains Medical Device Mat. 10606491 (GTIN:04056869015125) OUO Tomographic imager combining emission computed tomography with nuclear magnetic resonance 2 mMR Spine Matrix coil set
33 04056869014746 10185545 Contains Medical Device Mat. 10496545 (GTIN:04056869014937) LNI,LNH,MOS System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 Spine 32 MR Coil set 3T 098
34 04056869014722 10185543 Contains Medical Device Mat. 10496543 (GTIN:04056869014913) LNI,MOS,LNH System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging 2 PA 36 MR coil set 3T 098
35 04056869014616 10185502 Contains Medical Device Mat.10185552 (GTIN:04056869014784) LNH,MOS,LNI System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic 2 Flex large 4 MR coil set 1.5T
36 04056869014418 08626553 Contains Medical Device Mat. 8622644 (GTIN:04056869014296) LNH System, nuclear magnetic resonance imaging 2 3T Head Matrix MR coil kit
37 04056869014371 08625720 MRI Coil MOS,LNI,OUO,LNH Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectrosc Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,System, nuclear magnetic resonance imaging 2 3T Loop 4 cm MR coil
38 04056869014357 08625662 MRI Coil LNH,LNI,OUO,MOS System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,Coil, magnetic resonance, specialty 2 3T Loop 11cm MR coil
39 04056869014180 07575256 Contains Medical Device Mat. 7579472 (GTIN:04056869014265) LNI,MOS,LNH System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging 2 CP EXTREMITY MR COIL KIT
40 04056869011554 10092611 KPW Device, beam limiting, x-ray, diagnostic 2 Collimator ML01 II
41 04056869010144 10764562 DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE 2 Sensis Lite
42 04056869008981 10762473 Diagnostic Urology JAA System, x-ray, fluoroscopic, image-intensified 2 Uroskop Omnia Max
43 04056869008912 04779695 JAK System, x-ray, tomography, computed 2 Mat for patient table
44 04056869008899 04779588 JAK System, x-ray, tomography, computed 2 TransX
45 04056869008875 04779273 JAK System, x-ray, tomography, computed 2 Osteo-CT Plus4/VZ
46 04056869008783 08096864 JAK System, x-ray, tomography, computed 2 Mattress with flat surface cpl.
47 04056869008684 10187332 JAK System, x-ray, tomography, computed 2 Slide board MPT3
48 04056869008677 08096716 JAK System, x-ray, tomography, computed 2 Mattress
49 04056869008622 07445682 JAK System, x-ray, tomography, computed 2 Head rest 15 degree for head support
50 04056869008615 07445674 JAK System, x-ray, tomography, computed 2 Cushion Set
Other products with the same Product Codes "LNH, LNI, MOS"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00195278486813 SIGNA Hero SIGNA Hero System Medical Device Assembly - MDR NA GENERAL ELECTRIC COMPANY
2 00195278486813 SIGNA Hero SIGNA Hero System Medical Device Assembly - MDR NA GENERAL ELECTRIC COMPANY
3 00195278481382 SIGNA Artist Evo SIGNA Artist Evo System Medical Device, MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
4 00195278481382 SIGNA Artist Evo SIGNA Artist Evo System Medical Device, MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
5 00195278481382 SIGNA Artist Evo SIGNA Artist Evo System Medical Device, MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
6 00195278372307 SIGNA Voyager AIR Voyager AIR Medical Device Assembly NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
7 00195278372307 SIGNA Voyager AIR Voyager AIR Medical Device Assembly NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
8 00195278210036 SIGNA Artist SIGNA Artist Upgrade Medical Device- MDD NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
9 00195278126443 SIGNA Artist SIGNA Artist Upgrade Medical Device- MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
10 00195278124609 SIGNA Voyager Kizuna System Medical Device Assembly-MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
11 00195278124609 SIGNA Voyager Kizuna System Medical Device Assembly-MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
12 00195278122643 1.5T HD29 1.5T Signa HDxt Upgrade Kit Medical Device, MDR NA GENERAL ELECTRIC COMPANY
13 00195278117021 SIGNA Artist SIGNA Artist System Medical Device Assembly-MDR NA GE MEDICAL SYSTEMS (TIANJIN) CO., LTD.
14 00195278023643 SIGNA Architect NA GENERAL ELECTRIC COMPANY
15 00195278010797 SIGNA Premier SIGNA Premier System Medical Device Assembly, MDR NA GENERAL ELECTRIC COMPANY
16 00195278010797 SIGNA Premier SIGNA Premier System Medical Device Assembly, MDR NA GENERAL ELECTRIC COMPANY
17 00195278010797 SIGNA Premier SIGNA Premier System Medical Device Assembly, MDR NA GENERAL ELECTRIC COMPANY
18 00195278005502 SIGNA Pioneer SIGNA Pioneer System Medical Device Assembly - MDR NA GENERAL ELECTRIC COMPANY
19 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.
20 B669SMNS00011 SMNS0001 SMNS0001 MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system. MRIaudio Siemens System MRIAUDIO, INC.
21 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.
22 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.
23 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.
24 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.
25 B6693020 302 302 Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. MRIaudio Ear-Tip MRIAUDIO, INC.
26 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.
27 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.
28 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.
29 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.
30 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.
31 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.
32 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.
33 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.
34 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.
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 B545032000000 03-2000-00 MRopen 0.5 T ASG SUPERCONDUCTORS SPA
47 B440HVCP030 030004 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
48 B440HVCP020 020301 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
49 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.
50 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.