Other products from "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00884838108899 300007314091 HD 8Ch WRIST ARRAY (Receive Only) MOS Coil, Magnetic Resonance, Specialty 2 GE HEALTHCARE
2 00884838055322 781341 Magnetic Resonance Equipment LNI,LNH System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging 2 Ingenia 1.5T
3 00884838106970 6 830089 Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
4 00884838104570 ClarifEye - 1 002120 Software medical device. Intended for use by professional healthcare providers a Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy. OWB,LLZ,JAK,OLO Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological, Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological,System, X-Ray, Tomography, Computed,Orthopedic Stereotaxic Instrument 2 ClarifEye
5 00884838101890 StentBoost Live - 2 001017 Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. OWB,LLZ Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological 2 StentBoost Live
6 00884838100107 5 830089 Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
7 00884838099272 Azurion 7 B20 722226 Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (12-inch or 15-inch flat detector) and optional interface for an OR table. OWB,JAA Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified 2 Azurion
8 00884838095250 4.2 830089 Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
9 00884838085268 Azurion 7 M20 722079 Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. Optionally the ceiling-mounted configuration has an interface for an OR table OWB,JAA Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified 2 Azurion
10 00884838085220 2.2 Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
11 00884838093072 4.1 98960612681X Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
12 00884838091429 3.2 98960612660X Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
13 00884838090668 Onvision system 453561943492 Intended to be used during peripheral nerve block procedures. Tracks the positio Intended to be used during peripheral nerve block procedures. Tracks the position of the B.Braun Onvision needle tip position on the ultrasound image by overlaying a circle at the given location. IYO System, Imaging, Pulsed Echo, Ultrasonic 2 Onvision system
14 00884838087460 3.1 98960612483X Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
15 00884838085251 Azurion 7 M12 722078 Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. OWB,JAA Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified 2 Azurion
16 00884838085770 2.3 98960612341x Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
17 00884838084544 Philips Hemodynamic Application - 1 002010 Software medical device. Intended for use by professional healthcare providers f Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 2 Philips Hemodynamic Application
18 00884838080812 StentBoost Live - 1 001017 Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. OWB,LLZ Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological 2 StentBoost Live
19 00884838076730 1.2 Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
20 00884838075214 2.1 Cardiovascular Image and Information Management Solution (CVIS) LLZ System, image processing, radiological 2 IntelliSpace Cardiovascular
21 00884838059269 StentBoost - 4 001007 Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides high resolution visualization of stents in vessels. Supports the user in placing and deploying stents. OWB,LLZ Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological 2 StentBoost
22 00884838059238 MR-CT Roadmap - 1 001004 Software medical device, used with a Philips Interventional X-Ray System. Extens Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures. OWB,LLZ,JAK Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological, Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological,System, X-Ray, Tomography, Computed 2 MR-CT Roadmap
23 00884838059191 Interventional Workspot - 1 001000 Software medical device hosting platform, used with a Philips Interventional X-R Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices. LLZ,OWB System, Image Processing, Radiological,Interventional Fluoroscopic X-Ray System 2 Interventional Workspot
24 00884838083325 728231 JAK System, x-ray, tomography, computed 2 Brilliance CT
25 00884838114388 300009321831 Medial Array Coil VT MOS Coil, Magnetic Resonance, Specialty 2 DUNLEE SENITNELLE
26 00884838108646 Ingenia 1.5T 782140 Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
27 00884838108622 Ingenia Ambition X 782138 Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
28 00884838108615 Ingenia Elition S 782137 Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
29 00884838108608 Ingenia Elition X 782136 Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
30 00884838104129 Ingenia Elition X 782119 The Ingenia Elition X with the gradient and RF designs, as well as Compressed SE The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on superb image quality, improves patient handling setup time and combines this with accelerations in both 2D- and 3D scanning. LNH System, nuclear magnetic resonance imaging 2 Ingenia
31 00884838099715 Ingenia 1.5T 781315 LNH,LNI System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic 2 Ingenia
32 00884838099500 HA FlexTrak II 989710008732 The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
33 00884838099494 Tabletop extender 989603008792 A moveable tabletop which combined with the standard table top enables a maximum A moveable tabletop which combined with the standard table top enables a maximum field of view of 200cm. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
34 00884838099487 Trolley 989603008226 The Patient Trolley Frame is a stainless steel frame with four wheels for easy t The Patient Trolley Frame is a stainless steel frame with four wheels for easy transportation of the patient positioned on the system's tabletop. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
35 00884838099470 HA FlexTrak 989710006412 The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and all The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
36 00884838099463 FlexTrak 989710006402 The FlexTrak allows patient preparation for an examination while the previous pa The FlexTrak allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
37 00884838099456 Acoustic Hood 989603022784 "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
38 00884838099449 Acoustic Hood 989603020982 "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." LNH System, Nuclear Magnetic Resonance Imaging 2 Ingenia
39 00884838098343 Ingenia Ambition S 782108 Ingenia Ambition S LNH System, nuclear magnetic resonance imaging 2 Ingenia
40 00884838098336 Ingenia Elition X 782107 Ingenia Elition X LNH System, nuclear magnetic resonance imaging 2 Ingenia
41 00884838098329 Ingenia Elition S 782106 Ingenia Elition S LNH System, nuclear magnetic resonance imaging 2 Ingenia
42 00884838099340 AltaTrack equipment 4322 070 2535 X The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FO The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. DQK Computer, Diagnostic, Programmable 2 AltaTrack
43 00884838099043 Ingenia 1.5T 782115 Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with LNH System, nuclear magnetic resonance imaging 2 Ingenia
44 00884838098350 Ingenia Ambition X 782109 Ingenia Ambition X LNH System, nuclear magnetic resonance imaging 2 Ingenia
45 00884838095083 Smartpath to dStream for 3.0T 781270 LNH,LNI System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic 2 Ingenia
46 00884838098312 Ingenia 3.0T CX 782105 We’ve designed Ingenia 3.0T CX with the performance that helps you explore with We’ve designed Ingenia 3.0T CX with the performance that helps you explore with confidence, perform advanced clinical imaging that supports referrals, and conduct routine imaging efficiently. Thanks in part to exceptional Qua LNH System, nuclear magnetic resonance imaging 2 Ingenia
47 00884838098299 Ingenia 3.0T 782103 Ingenia 3.0T LNH System, nuclear magnetic resonance imaging 2 Ingenia
48 00884838098275 Ingenia 1.5T 782101 Ingenia 1.5T LNH System, nuclear magnetic resonance imaging 2 Ingenia
49 00884838095076 Smartpath to dStream for 1.5T 781260 MRDD Equipment LNI,LNH System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging 2 Ingenia
50 00884838083653 6.5 The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series tha The IntelliSpace Portal IX V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal IX V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading. LLZ System, image processing, radiological 2 IntelliSpace Portal IX
Other products with the same Product Code "LNH"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B672MYOSTRAIN050102 5.1.2 MyoStrain software is an image processing device that post-processes strain-enco MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements MyoStrain MYOCARDIAL SOLUTIONS, INC.
2 B669SMNS00011 SMNS0001 SMNS0001 MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system. MRIaudio Siemens System MRIAUDIO, INC.
3 B66935011 3501 3501 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solu The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection. MRIaudioPREM1001 with MRIview MRIAUDIO, INC.
4 B66935001 3500 3500 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solu The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection. MRIaudioPREM1000 with MRIview MRIAUDIO, INC.
5 B6693301 330 330 MRI-safe ear defenders provide patients with 29dB of hearing protection and allo MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection. MRIaudio Over-Ear Headphones MRIAUDIO, INC.
6 B6693201 320 320 MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB hearing protection and allows patients to listen to audio entertainment. Standard two prong pneumatic headphone connection. Designed for use with MRIaudio Ear-tips. Wishbone Headset MRIAUDIO, INC.
7 B6693020 302 302 Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. MRIaudio Ear-Tip MRIAUDIO, INC.
8 B66930001 3000 3000 The MRIview is an MRI conditional video solution that provides MRI patients with The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment. MRIview MRIAUDIO, INC.
9 B66916001 1600 1600 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1600 MRIAUDIO, INC.
10 B66915061 1506 1506 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1506 MRIAUDIO, INC.
11 B66915051 1505 1505 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1505 MRIAUDIO, INC.
12 B66914001 1400 1400 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudio1400 MRIAUDIO, INC.
13 B6691011 101 101 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing. 3G Transducer MRIAUDIO, INC.
14 B66910021 1002 1002 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudioPREM1002 MRIAUDIO, INC.
15 B66910011 1001 1001 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudioPREM1001 MRIAUDIO, INC.
16 B66910001 1000 1000 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. MRIaudioPREM1000 MRIAUDIO, INC.
17 B554MRCP1000 1.0 MRCP+v1 is indicated for use as a software-based image processing system for non MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment.MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols.MRCP+v1 is suitable for all patients not contra-indicated for MRI. MRCP+ PERSPECTUM LTD
18 B554LMS5000 5.0.0 LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnosti LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
19 B554LMS4000 4.0.0 LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may optionally be computed using the DIXON or LMS MOST methodologies. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
20 B554LMS3500 3.5.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
21 B554LMS3400 3.4.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
22 B554LMS3300 3.3.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
23 B554LMS3200 3.2.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
24 B554LMS3100 3.1.0 LiverMultiScan (LMSv3) is a standalone software device. The purpose of the Liver LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). The LiverMultiScan (LMSv3) is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is then sent to an interpreting clinician.The interpreting clinician needs to take into consideration the device’s limitations and accuracy during clinical interpretation.LiverMultiScan (LMSv3) is not intended to replace the established procedures for the assessment of a patients liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.The device is intended to be used by a trained operator to generate metrics for subsequent interpretation by a clinician.The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan (LMSv3) metrics. The purpose of a LiverMultiScan (LMSv3) metrics is to provide imaging information to assist in characterizing tissue in the liver, which are additional to existing methods for obtaining information relating to the liver. LiverMultiScan (LMSv3) metrics are not intended to replace any existing diagnostic source of information, but can be used to identify patients who LiverMultiScan PERSPECTUM LTD
25 B554LMS2100 2.1 LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan PERSPECTUM LTD
26 B554LMS2000 2.0 LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan PERSPECTUM LTD
27 B554HEPATICA100 1.0.0 Hepatica (Hepatica v1) is a post-processing medical device software that present Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making. Hepatica PERSPECTUM LTD
28 B545032000000 03-2000-00 MRopen 0.5 T ASG SUPERCONDUCTORS SPA
29 B440HVCP030 030004 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
30 B440HVCP020 020301 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
31 B358PCI01PP0 4.1 PCI01PP Prism Process® software is used in conjunction with a Magnetic Resonance scanner Prism Process® software is used in conjunction with a Magnetic Resonance scanner to process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI), and other MRI data sets. Prism Process performs post-processing for quality control and subsequent viewing of fMRI and other data. Prism Process PRISM CLINICAL IMAGING, INC.
32 B358PCI01PA0 4.1 PCI01PA Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned for fMRI. The patient’s responses and image data from the MRI scanner are stored for use by Prism Process. Prism Acquire PRISM CLINICAL IMAGING, INC.
33 B237ZXLASR110 ZXL-ASR-11 GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp Zephyr Patient Positioning and Transfer System DIACOR, INC.
34 B237ZXLASR100 ZXL-ASR-10 GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp Zephyr Patient Positioning and Transfer System DIACOR, INC.
35 B237ZXLASB060 ZXL-ASB-06 Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems Zephyr Patient Positioning and Transfer System DIACOR, INC.
36 B237ZXLASB050 ZXL-ASB-05 Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM Zephyr Patient Positioning and Transfer System DIACOR, INC.
37 B237ZXLADK510 ZXL-ADK-51 Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) foot end stop Zephyr Patient Positioning and Transfer System DIACOR, INC.
38 B237ZXLADK500 ZXL-ADK-50 Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar a Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit for MR couch Zephyr Patient Positioning and Transfer System DIACOR, INC.
39 B237ZXLADK100 ZXL-ADK-10 Zephyr Docking Kit 50cm for GE PET/MR Flat Table Top (FTT) Zephyr Patient Positioning and Transfer System DIACOR, INC.
40 B237ZXLACI140 ZXL-ACI-14 Zephyr IR-S Collision Indicators for GE GEM MR Cart Zephyr Patient Positioning and Transfer System DIACOR, INC.
41 B237ZXLACI130 ZXL-ACI-13 Zephyr IR-S Collision Indicators for GE Premier Fixed Couch Zephyr Patient Positioning and Transfer System DIACOR, INC.
42 B237ZXLACI120 ZXL-ACI-12 Zephyr IR-A Collision Indicators for GE MOTUS MR Cart Zephyr Patient Positioning and Transfer System DIACOR, INC.
43 B237ZXLACI110 ZXL-ACI-11 Zephyr IR-A Collision Indicators for GE GEM MR Cart Zephyr Patient Positioning and Transfer System DIACOR, INC.
44 B237ZXLACI100 ZXL-ACI-10 Zephyr IR-S Collision Indicators for Philips Ingenia MR-RT System Zephyr Patient Positioning and Transfer System DIACOR, INC.
45 B237ZXLABP100 ZXL-APB-10 Zephyr HP Accessory - Baseplate for S-Style thermoplastic masks Zephyr Patient Positioning and Transfer System DIACOR, INC.
46 B01611160006Z0 11160006Z 11160006Z Radiation therapy QA device. 15-25 MV QED Detector (1.5m Cable) SUN NUCLEAR CORP.
47 B01611160003Z0 11160003Z 11160003Z Radiation therapy QA device. 15-25MV QED Detector (3m Cable) SUN NUCLEAR CORP.
48 B01611160002Z0 11160002Z 11160002Z Radiation therapy QA device. 15-25MV QED Detector (3m Cable) SUN NUCLEAR CORP.
49 B01611150006Z0 11150006Z 11150006Z Radiation therapy QA device. 6-12MV QED Detector (1.5m Cable) SUN NUCLEAR CORP.
50 B01611150003Z0 11150003Z 11150003Z Radiation therapy QA device. 6-12MV QED Detector (3m Cable) SUN NUCLEAR CORP.