Other products from "CANON MEDICAL SYSTEMS CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04987670104831 MRT-1550/WK LNH System, Nuclear Magnetic Resonance Imaging 2 Vantage Fortian
2 04987670101649 MRT-3010 Vantage Titan 3T LNH System, nuclear magnetic resonance imaging 2 Vantage Titan 3T
3 04987670004520 PET-512MD MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
4 04987670004513 PEI-512VX ITX Transducer, Ultrasonic, Diagnostic 2 MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
5 04987670003103 PET-512MC MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
6 04987670002762 PC-50M CW DOPPLER PENCIL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 CW DOPPLER PENCIL TRANSDUCER
7 04987670001642 PVM-651VT ENDOVAGINAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 ENDOVAGINAL TRANSDUCER
8 04987670001635 PVM-621VT ENDOVAGINAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 ENDOVAGINAL TRANSDUCER
9 04987670001499 PVG-600S INTRACORPOREAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 INTRACORPOREAL TRANSDUCER
10 04987670000607 PET-511BTM MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
11 04987670000584 PET-508MA MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
12 04987670000492 PC-50V CW DOPPLER PENCIL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 CW DOPPLER PENCIL TRANSDUCER
13 04987670000485 PC-20M CW DOPPLER PENCIL TRANSDUCER ITX Transducer, ultrasonic, diagnostic 2 CW DOPPLER PENCIL TRANSDUCER
14 04987670103353 CUS-AA550 DIAGNOSTIC ULTRASOUND SYSTEM ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
15 04987670103346 CUS-AA450 DIAGNOSTIC ULTRASOUND SYSTEM ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
16 04987670102981 TUS-AI600 DIAGNOSTIC ULTRASOUND SYSTEM ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
17 04987670103780 CUS-AA000 IYN,IYO,ITX System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultras System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
18 04987670103469 CUS-X100G DIAGNOSTIC ULTRASOUND SYSTEM ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
19 04987670103452 CUS-X200G DIAGNOSTIC ULTRASOUND SYSTEM IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
20 04987670102523 TUS-AI900 DIAGNOSTIC ULTRASOUND SYSTEM IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
21 04987670102516 TUS-AI800 DIAGNOSTIC ULTRASOUND SYSTEM IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
22 04987670102509 TUS-AI700 DIAGNOSTIC ULTRASOUND SYSTEM IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
23 04987670102400 MRT-1504 This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vantage Titan. LNH System, nuclear magnetic resonance imaging 2 TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan
24 04987670102370 USWP-100A 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE LLZ System, image processing, radiological 2 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
25 04987670101670 BLR-15AA KPW Device, beam limiting, x-ray, diagnostic 2 X-ray beam limiting device
26 04987670101632 MRT-2020 This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vantage Elan. LNH System, nuclear magnetic resonance imaging 2 TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan
27 04987670101601 MRT-1510 This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vantage Titan. LNH System, nuclear magnetic resonance imaging 2 TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan
28 04987670101595 MJQJ-167A QD KNEE/FOOT COIL MOS Coil, magnetic resonance, specialty 2 QD KNEE/FOOT COIL
29 04987670101267 MJAH-167A Octave SPEEDER Head MOS Coil, magnetic resonance, specialty 2 Octave SPEEDER Head
30 04987670100765 TUS-X200S DIAGNOSTIC ULTRASOUND SYSTEM IYN,ITX,IYO System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
31 04987670100758 TUS-X200 DIAGNOSTIC ULTRASOUND SYSTEM IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
32 04987670100741 TUS-X100S DIAGNOSTIC ULTRASOUND SYSTEM IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
33 04987670100734 TUS-X100 DIAGNOSTIC ULTRASOUND SYSTEM IYO,IYN,ITX System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic 2 DIAGNOSTIC ULTRASOUND SYSTEM
34 04987670100727 TUS-A500 DIAGNOSTIC ULTRASOUND SYSTEM ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
35 04987670100710 TUS-A400 DIAGNOSTIC ULTRASOUND SYSTEM IYO,ITX,IYN System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
36 04987670100703 TUS-A300 DIAGNOSTIC ULTRASOUND SYSTEM ITX,IYN,IYO Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic 2 DIAGNOSTIC ULTRASOUND SYSTEM
37 04987670001413 PVF-620ST INTRA-CORPOREAL PROBE ITX Transducer, ultrasonic, diagnostic 2 INTRA-CORPOREAL PROBE
38 04987670102615 MRT-3020 Vantage Galan 3T LNH System, nuclear magnetic resonance imaging 2 Vantage Galan 3T
39 04987670102196 DRAD-3000E DIGITAL RADIOGRAPHY SYSTEM MQB Solid state x-ray imager (flat panel/digital imager) 2 DIGITAL RADIOGRAPHY SYSTEM
40 04987670101533 MJLC-157G Phi150 Flex Coil LNH System, nuclear magnetic resonance imaging 2 Phi150 Flex Coil
41 04987670101502 MJLC-107G Phi100 Flex Coil LNH System, nuclear magnetic resonance imaging 2 Phi100 Flex Coil
42 04987670101359 MJAJ-197A 4ch Flex SPEEDER MOS Coil, magnetic resonance, specialty 2 4ch Flex SPEEDER
43 04987670101342 MJAJ-192A 4ch Flex SPEEDER MOS Coil, magnetic resonance, specialty 2 4ch Flex SPEEDER
44 04987670100222 INFX-8000V INTERVENTIONAL ANGIOGRAPHY SYSTEM OWB,JAA,IZI Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic 2 INTERVENTIONAL ANGIOGRAPHY SYSTEM
45 04987670100215 INFX-8000H INTERVENTIONAL ANGIOGRAPHY SYSTEM MQB Solid state x-ray imager (flat panel/digital imager) 2 INTERVENTIONAL ANGIOGRAPHY SYSTEM
46 04987670100208 INFX-8000F INTERVENTIONAL ANGIOGRAPHY SYSTEM MQB Solid state x-ray imager (flat panel/digital imager) 2 INTERVENTIONAL ANGIOGRAPHY SYSTEM
47 04987670100192 INFX-8000C INTERVENTIONAL ANGIOGRAPHY SYSTEM JAA,OWB System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray system 2 INTERVENTIONAL ANGIOGRAPHY SYSTEM
48 04987670100116 DREX-KL80 DIAGNOSTIC X-RAY SYSTEM KALARE JAA System, x-ray, fluoroscopic, image-intensified 2 DIAGNOSTIC X-RAY SYSTEM KALARE
49 04987670101236 MJAH-127A Atlas SPEEDER Head LNH System, nuclear magnetic resonance imaging 2 Atlas SPEEDER Head
50 04987670101199 MJAB-167A Atlas SPEEDER Body LNH System, nuclear magnetic resonance imaging 2 Atlas SPEEDER Body
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.