No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B237ZTGAIX040 | ZTG-AIX-04 | Zephyr MR Conditional Stretcher Accessory - Stretcher Indexing. Includes removab Zephyr MR Conditional Stretcher Accessory - Stretcher Indexing. Includes removable side stops and floor indexing kits. (ZTG-AIX-02 also required) | FPO | Stretcher, Wheeled | 2 | Zephyr Patient Stretcher | |
2 | B237ZTGAIX010 | ZTG-AIX-01 | Zephyr Procedural Stretcher Accessory - Stretcher Indexing. Includes removable Zephyr Procedural Stretcher Accessory - Stretcher Indexing. Includes removable side stops and floor indexing kits. (ZTG-AIX-02 also required) | FPO | Stretcher, Wheeled | 2 | Zephyr Patient Stretcher | |
3 | B237ZTGAIB010 | ZTG-AIB-01 | Zephyr Procedural Stretcher Accessory - Dräger Mobile Anesthesia Interface Bar | FPO | Stretcher, Wheeled | 2 | Zephyr Patient Stretcher | |
4 | B237ZTGACA010 | ZTG-ACA-01 | Zephyr Stretcher Accessory - C-Arm Extension Table | FPO | Stretcher, Wheeled | 2 | Zephyr Patient Stretcher | |
5 | B237ZTG40 | ZTG-4 | Zephyr Patient Stretcher | FPO | Stretcher, Wheeled | 2 | Zephyr Patient Stretcher | |
6 | B237ZTG20 | ZTG-2 | Zephyr MR Conditional Stretcher | FPO | Stretcher, Wheeled | 2 | Zephyr Patient Stretcher | |
7 | B237ZXLZHP200 | ZXL-ZHP-20 | Zephyr HP PRO Head and Neck Hover System | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
8 | B237ZXLZHP100 | ZXL-ZHP-10 | Zephyr HP Head and Neck Hover System | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
9 | B237ZXLZGE100 | ZXL-ZGE-10 | Zephyr XL Patient Hover Board for GE MRI Scanners | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
10 | B237ZXLTGE130 | ZXL-TGE-13 | Diacor Carbon Fiber GE CT Overlay with Stops | KXJ | Table, Radiologic | 2 | Diacor CT Overlay | |
11 | B237ZXLIRS200 | ZXL-IRS-20 | Zephyr IR-S Hoverboard with mounts for Skull Clamp for Philips MR. Includes the Zephyr IR-S Hoverboard with mounts for Skull Clamp for Philips MR. Includes the Zephyr IR-S Hoverboard, Patient Pad with integrated Transfer Handles, Integrated IV Pole, Hoverboard Security Straps, and Patient Security Straps | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
12 | B237ZXLIRS100 | ZXL-IRS-10 | Zephyr IR Transfer Board Skull Clamp Version | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
13 | B237ZXLIRN100 | ZXL-IRN-10 | Zephyr IR-N Hover Board for neuro-related patient transfer | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
14 | B237ZXLIRG100 | ZXL-IRG-10 | Zephyr IR Patient Transfer Board | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
15 | B237ZXLIRA100 | ZXL-IRA-10 | Zephyr IR Articulating Hoverboard with mounts for skull clamp | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
16 | B237ZXLASR110 | ZXL-ASR-11 | GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp | LHN,LNH | System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Re System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
17 | B237ZXLASR100 | ZXL-ASR-10 | GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp | LHN,LNH | System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Re System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
18 | B237ZXLASB060 | ZXL-ASB-06 | Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems | LHN,LNH | System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Re System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
19 | B237ZXLASB050 | ZXL-ASB-05 | Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM | LHN,LNH | System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Re System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
20 | B237ZXLASB040 | ZXL-ASB-04 | Zephyr Docking Side Stop Bar - (1): Used on 50cm Non-Indexed Couch | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
21 | B237ZXLASB030 | ZXL-ASB-03 | Zephyr Docking Side Stop Bar - (1): Used on 53cm Elekta iBeam Couch | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
22 | B237ZXLASB020 | ZXL-ASB-02 | Zephyr Docking Side Stop Bar for 50cm XL - (1): Used on 53cm Varian Couch | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
23 | B237ZXLASB010 | ZXL-ASB-01 | Zephyr Docking Side Stop Bar - (1): Used on 53cm Varian Couch | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
24 | B237ZXLAOT150 | ZXL-AOT-15 | OTP (Over-travel protection) solution kit for Hillrom/Trumpf Carbon Floatline | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
25 | B237ZXLAOT140 | ZXL-AOT-14 | OTP (Over-travel protection) solution kit for Canon Angio Imaging Tables | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
26 | B237ZXLAOT130 | ZXL-AOT-13 | OTP (Over-travel protection) solution kit for Trumpf Hybrid Carbon Fiber Table Top | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
27 | B237ZXLAOT120 | ZXL-AOT-12 | OTP (Over-travel protection) solution kit for GE Omega or IQ Tilt Tables | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
28 | B237ZXLAOT110 | ZXL-AOT-11 | OTP (Over-travel protection) solution kit for Maquet Magnus 1180 Imaging Table | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
29 | B237ZXLAOT100 | ZXL-AOT-10 | OTP (Over-travel protection) solution kit for Philips AD7NT Imaging Table | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
30 | 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 | LHN,LNH | System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Re System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
31 | B237ZXLADK100 | ZXL-ADK-10 | Zephyr Docking Kit 50cm for GE PET/MR Flat Table Top (FTT) | LHN,LNH | System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Re System, Radiation Therapy, Charged-Particle, Medical,System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
32 | B237ZXLADK090 | ZXL-ADK-09 | Zephyr Docking Kit 50cm Hitachi Treatment Couch: Includes (1) side stop bar and Zephyr Docking Kit 50cm Hitachi Treatment Couch: Includes (1) side stop bar and (1) reversible foot end docking plate | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
33 | B237ZXLADK080 | ZXL-ADK-08 | Zephyr Docking Kit ___cm Trumpf Imaging Couch Includes (1) side stop bar and (1) Zephyr Docking Kit ___cm Trumpf Imaging Couch Includes (1) side stop bar and (1) reversible foot end docking kit. | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
34 | B237ZXLADK070 | ZXL-ADK-07 | Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit. | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
35 | B237ZXLADK060 | ZXL-ADK-06 | Zephyr Docking Kit for 50cm XL on Varian. Includes (1) side stop bar and (1) rev Zephyr Docking Kit for 50cm XL on Varian. Includes (1) side stop bar and (1) reversible foot end docking kit. | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
36 | B237ZXLADK050 | ZXL-ADK-05 | Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit. | LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | Zephyr Patient Positioning and Transfer System | |
37 | B237ZXLACI140 | ZXL-ACI-14 | Zephyr IR-S Collision Indicators for GE GEM MR Cart | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
38 | B237ZXLACI130 | ZXL-ACI-13 | Zephyr IR-S Collision Indicators for GE Premier Fixed Couch | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
39 | B237ZXLACI120 | ZXL-ACI-12 | Zephyr IR-A Collision Indicators for GE MOTUS MR Cart | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
40 | B237ZXLACI100 | ZXL-ACI-10 | Zephyr IR-S Collision Indicators for Philips Ingenia MR-RT System | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
41 | B237ZXLABP100 | ZXL-APB-10 | Zephyr HP Accessory - Baseplate for S-Style thermoplastic masks | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Zephyr Patient Positioning and Transfer System | |
42 | B237ZXL50 | ZXL-5 | Zephyr XL Patient Hover Board LP | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
43 | B237ZXL40 | ZXL-4 | Zephyr XL Patient Hover Board 50cm | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
44 | B237ZXL30 | ZXL-3 | Zephyr XL Patient Hover Board 50cm w/ Gating Plate | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
45 | B237ZXL20 | ZXL-2 | Zephyr XL Patient Hover Board for MedPhoton Imaging Tables | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
46 | B237ZXL10 | ZXL-1 | Zephyr XL Patient Hover Board | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
47 | B237ZEPAUB700 | ZEP-AUB-70 | Zephyr HDR Accessory - Universal Clamp Bracket for RPD Universal Clamp | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
48 | B237ZEPAUB610 | ZEP-AUB-61 | Zephyr HDR Accessory - Universal Clamp Bracket for Varian Universal Clamp (Rev2) | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
49 | B237ZEPAUB600 | ZEP-AUB-60 | Zephyr HDR Accessory - Universal Clamp Bracket for Varian Universal Clamp | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System | |
50 | B237ZEPAUB530 | ZEP-AUB-53 | Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 3 screw mount design | FRZ | Device, Patient Transfer, Powered | 2 | Zephyr Patient Positioning and Transfer System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B867RTC55000 | RTC550 | Audio/Video MRI Patient comfort device | CinemaVision | RESONANCE TECHNOLOGY, INC. | |
2 | B673MYOSTRAIN05040 | 5.4 | 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, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis. | MyoStrain | MYOCARDIAL SOLUTIONS, INC. | |
3 | B673MYOSTRAIN0502030 | 5.2.3 | 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, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis. | MyoStrain | MYOCARDIAL SOLUTIONS, INC. | |
4 | B673MYOSTRAIN0502020 | 5.2.2 | 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. | |
5 | 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. | |
6 | B669SMNS00011 | SMNS0001 | SMNS0001 | MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system. | MRIaudio Siemens System | MRIAUDIO, INC. |
7 | 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. |
8 | 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. |
9 | 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. |
10 | 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. |
11 | B6693020 | 302 | 302 | Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR. | MRIaudio Ear-Tip | MRIAUDIO, INC. |
12 | 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. |
13 | 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. |
14 | 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. |
15 | 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. |
16 | 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. |
17 | 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. |
18 | 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. |
19 | 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. |
20 | 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. |
21 | 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 | |
22 | 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 | |
23 | 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 | |
24 | 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 | |
25 | 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 | |
26 | 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 | |
27 | 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 | |
28 | 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 | |
29 | 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 | |
30 | 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 | |
31 | 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 | |
32 | B545032000000 | 03-2000-00 | MRopen 0.5 T | ASG SUPERCONDUCTORS SPA | ||
33 | B440HVCP030 | 030004 | HVCP | HeartVista Cardiac Package | HeartVista Cardiac Package | HEARTVISTA, INC. |
34 | B440HVCP020 | 020301 | HVCP | HeartVista Cardiac Package | HeartVista Cardiac Package | HEARTVISTA, INC. |
35 | 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. |
36 | 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. |
37 | B237ZXLASR110 | ZXL-ASR-11 | GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
38 | B237ZXLASR110 | ZXL-ASR-11 | GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
39 | B237ZXLASR100 | ZXL-ASR-10 | GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
40 | B237ZXLASR100 | ZXL-ASR-10 | GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
41 | 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. | |
42 | 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. | |
43 | B237ZXLASB050 | ZXL-ASB-05 | Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
44 | B237ZXLASB050 | ZXL-ASB-05 | Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
45 | B237ZXLASB040 | ZXL-ASB-04 | Zephyr Docking Side Stop Bar - (1): Used on 50cm Non-Indexed Couch | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
46 | B237ZXLASB030 | ZXL-ASB-03 | Zephyr Docking Side Stop Bar - (1): Used on 53cm Elekta iBeam Couch | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
47 | B237ZXLASB020 | ZXL-ASB-02 | Zephyr Docking Side Stop Bar for 50cm XL - (1): Used on 53cm Varian Couch | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
48 | B237ZXLASB010 | ZXL-ASB-01 | Zephyr Docking Side Stop Bar - (1): Used on 53cm Varian Couch | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
49 | B237ZXLAOT150 | ZXL-AOT-15 | OTP (Over-travel protection) solution kit for Hillrom/Trumpf Carbon Floatline | Zephyr Patient Positioning and Transfer System | DIACOR, INC. | |
50 | B237ZXLAOT140 | ZXL-AOT-14 | OTP (Over-travel protection) solution kit for Canon Angio Imaging Tables | Zephyr Patient Positioning and Transfer System | DIACOR, INC. |