Other products from "SIEMENS SHENZHEN MAGNETIC RESONANCE LTD."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04056869049779 10164772 Contains Medical Device Mat. 10498865 (GTIN:04056869038933) LNH System, nuclear magnetic resonance imaging 2 1.5T 4 Ch Flex large MR coil kit
2 04056869049694 10019365 Contains Medical Device Mat. 8635620 (GTIN:04056869038865) LNH System, nuclear magnetic resonance imaging 2 Shoulder coil kit c035
3 04056869049649 10019257 Contains Medical Device Mat. 8635562 (GTIN:04056869038803) LNH System, nuclear magnetic resonance imaging 2 Neck coil large C0.35T Kit
4 04056869044538 10840816 MRI Scanner 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 MAGNETOM Sempra
5 04056869044521 10840815 MRI Scanner 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 MAGNETOM Sempra
6 04056869042190 10838403 Contains Medical Device Mat. 10838404 (GTIN:04056869039053) LNH System, nuclear magnetic resonance imaging 2 Head/Neck 10 MR Coil Set 1.5T
7 04056869039053 10838404 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Head/Neck 10 MR Coil 1.5T
8 04056869038933 10498865 MRI Coil LNH System, nuclear magnetic resonance imaging 2 1.5T 4 Ch Flex large MR coil
9 04056869038872 08635679 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Neck Coil M C035
10 04056869038841 08635604 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Multipurpose Coil 16S C035
11 04056869038803 08635562 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Neck Coil L C035
12 04056869038780 08635547 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Body Spine Array S C035
13 04056869015354 10655081 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Extremity coil 18
14 04056869015347 10654892 Contains Medical Device Mat. 10654891 (GTIN:04056869015330) LNH,LNI,MOS,OUO System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,Tomographic imager combining emission computed tomography with nuclear magnetic resonance 2 special purpose coil 4 set
15 04056869015101 10500100 Contains Medical Device Mat. 10500090 (GTIN:04056869015040) 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 2 098 3T Foot Ankle Coil Set
16 04056869015057 10500093 Contains Medical Devices Mat. 10500081 (GTIN:04056869014999) and Mat.10500082 (G Contains Medical Devices Mat. 10500081 (GTIN:04056869014999) and Mat.10500082 (GTIN:04056869015002) 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 1.5T Shoulder Coil Set
17 04056869015019 10500084 Contains Medical Device Mat. 10500084 (GTIN:04056869015019) 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 2 098 1.5 T Foot Ankle Coil
18 04056869014975 10499848 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 Hand\wrist 16 1.5T
19 04056869281896 11407660 MOS Coil, magnetic resonance, specialty 2 Head/Neck Coil Set
20 04056869281773 11408427 LNH,MOS System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 MAGNETOM Free.Star
21 04056869281766 11408426 LNH,MOS System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 MAGNETOM Free.Star
22 04056869231204 11293128 MOS,LNI,LNH Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectrosc Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging 2 iTX Extremity 18 Flare
23 04056869049830 10352333 Contains Medical Device Mat. 10351766 (GTIN:04056869039015) LNH System, nuclear magnetic resonance imaging 2 Focus Shoulder Array Coil Set
24 04056869049687 10019290 Contains Medical Device Mat. 8635513 (GTIN:04056869038889) LNH System, nuclear magnetic resonance imaging 2 Body spine array XL kit
25 04056869049663 10019287 Contains Medical Device Mat. 8635547 (GTIN:04056869038780) LNH System, nuclear magnetic resonance imaging 2 Body Spine Array S MR Coil Kit
26 04056869038995 10131487 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Body Matrix coil
27 04056869038858 08635612 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Multipurpose Coil 21 C035
28 04056869038797 08635554 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Head Array C035
29 04056869038766 08635505 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Body Spine Array XXL C035
30 04056869022970 10840788 contains Medical Device Mat.: 10840787 (GTIN: 04056869053431) 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 Tx/Rx Knee 18 Coil Kit 3T
31 04056869020495 10498833 MRI Scanner LNH,MOS System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 MAGNETOM C!
32 04056869015507 10837234 Contains Medical Device Mat. 10837233 (GTIN:04056869015491) 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 3T Foot Ankle 16 pTx Kit
33 04056869015330 10654891 MRI Coil MOS,OUO,LNH,LNI Coil, magnetic resonance, specialty,Tomographic imager combining emission comput Coil, magnetic resonance, specialty,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic 2 special purpose coil 4
34 04056869015309 10654290 Contains Medical Device Mat. 10654289 (GTIN:04056869015293) 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 Body 6 kit 030
35 04056869281759 11408424 MOS,LNH Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging 2 MAGNETOM Free.Max
36 04056869281742 11408425 MRI Scanner LNH,MOS System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty 2 MAGNETOM Free.Max
37 04056869231112 11293133 MOS Coil, magnetic resonance, specialty 2 Flex Large 8 Coil Set 1.5T
38 04056869049885 10499481 Contains Medical Device Mat. 10353300 (GTIN:04056869039039) LNH System, nuclear magnetic resonance imaging 2 14-Channel Extremity Coil SET
39 04056869049762 10164722 Contains Medical Device Mat. 10351919 (GTIN:04056869039022) LNH System, nuclear magnetic resonance imaging 2 Extremity MATRIX KIT 011
40 04056869049724 10131482 Contains Medical Device Mat. 10131483 (GTIN:04056869038988) LNH System, nuclear magnetic resonance imaging 2 Head Array MR Coil Kit
41 04056869049656 10019258 Contains Medical Device Mat. 8635554 (GTIN:04056869038797) LNH System, nuclear magnetic resonance imaging 2 Head Array MR Coil Kit
42 04056869049618 10019208 Contains Medical Device Mat. 8635596 (GTIN:04056869038834) LNH System, nuclear magnetic resonance imaging 2 Extremity small coil kit
43 04056869042299 10019289 Contains Medical Device Mat. 8635521 (GTIN:04056869039169) LNH System, nuclear magnetic resonance imaging 2 Body Spine Array L MR Coil Kit
44 04056869042206 10838407 Contains Medical Device Mat. 10838408 (GTIN:04056869039060) LNH System, nuclear magnetic resonance imaging 2 Spine matrix 18 MR Coil Set 1.5T
45 04056869039169 08635521 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Body spine array L C035
46 04056869039145 10838426 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Foot/Ankle 10 MR Coil 1.5T
47 04056869039084 10838412 MRI Coil LNH System, nuclear magnetic resonance imaging 2 iTX Extremity 18 MR coil 1.5T
48 04056869039022 10351919 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Extremity Matrix coil
49 04056869039015 10351766 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Focus Shoulder Array Coil, large
50 04056869038957 10352367 MRI Coil LNH System, nuclear magnetic resonance imaging 2 Focus Shoulder Array Coil, small
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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
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