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System, Nuclear Magnetic Resonance Imaging

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Name
Company Name
Description
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Achieva 1.5T
Philips Medical Systems Nederland B.V.
Magnetic Resonance Equipment
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Ingenia
Philips Medical Systems Nederland B.V.
MRDD Equipment
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Ingenia
Philips Medical Systems Nederland B.V.
MRDD Equipment
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Medium Torso Coil (Receive Only) – Top
VIEWRAY INCORPORATED
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Head Neck Coil (Receive Only) – Top
VIEWRAY INCORPORATED
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MRIdian Linac System
VIEWRAY INCORPORATED
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Medium Torso Coil (Receive Only) – Bottom
VIEWRAY INCORPORATED
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Head Neck Coil (Receive Only) – Bottom
VIEWRAY INCORPORATED
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NOVA
VASSOL, INC.
Vascular Flow Analysis System
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STAGE
Spintech, Inc.
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
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STAGE
Spintech, Inc.
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
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NEONA 1.5T MRI System
TIME MEDICAL SYSTEMS
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EMMA 1.5T MRI System
TIME MEDICAL SYSTEMS
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PICA Whole-body MRI System
TIME MEDICAL SYSTEMS
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Promaxo MRI System
Promaxo, Inc.
Magnetic Resonance Imaging System, Auxiliary Rack
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Promaxo MRI System
Promaxo, Inc.
Magnetic Resonance Imaging System, Magnet Cart
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FIRMM®
Turing Medical Technologies Inc
Framewise Integrated Real-Time MRI Monitoring
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Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner
HYPERFINE RESEARCH, INC.
Swoop POC MRI Scanner (Mk1.8 version)
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Swoop Point-of-Care Magnetic Resonance Imaging Scanner
HYPERFINE RESEARCH, INC.
The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.
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Swoop Site Quality Assurance Phantom
HYPERFINE RESEARCH, INC.
The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.
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Embrace Neonatal MRI System
ASPECT IMAGING LTD
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
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WristView
ASPECT IMAGING LTD
The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume is an ellipsoid with dimensions of 120mm X 120 mm X 70mm around the magnet center. The overall dimensions of the magnet assembly are 140 cm x 100 cm x 235 cm [with patient trolley].
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IMRIS iMRI 3T V
DEERFIELD IMAGING, INC.
IMRIS IMRI 3T V
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Neuro III-SV iMRI System
DEERFIELD IMAGING, INC.
Neuro III-SV Multi-Room Imaging Suite MR30LS Enhancement OR-DR, 116189-000
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Neuro III-SV iMRI System
DEERFIELD IMAGING, INC.
Neuro III-SV Multi-Room Imaging Suite MR30RS Enhancement [OR-DR-OR], 118396-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System AR-DR MR30RS,105824-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System AR-DR-AR, MR30R, 105826-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System AR-DR-OR, MR30R, 105828-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000
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iMRX System
DEERFIELD IMAGING, INC.
iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000
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iMRI 1.5T A
DEERFIELD IMAGING, INC.
IMRIS SAE OR-DR-OR Full Body Imaging, 116116-000
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iMRI 1.5T A
DEERFIELD IMAGING, INC.
IMRIS SAE OR-DR Partial Body Imaging, 116115-000
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iMRI 1.5T A
DEERFIELD IMAGING, INC.
IMRIS SAE OR-DR-OR Full Body Imaging, 116114-000
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iMRI 1.5T A
DEERFIELD IMAGING, INC.
IMRIS SAE OR-DR-OR Partial Body Imaging, 116113-000
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iMRI 3T S
DEERFIELD IMAGING, INC.
IMRIS SSK OR-DR Full Body Imaging, 116119-000
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iMRI 3T S
DEERFIELD IMAGING, INC.
IMRIS SSK OR-DR Partial Body Imaging, 116118-000
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iMRI 3T S
DEERFIELD IMAGING, INC.
IMRIS SSK OR-DR-OR Full Body Imaging,116117-000
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iMRI 3T S
DEERFIELD IMAGING, INC.
IMRIS SSK OR-DR-OR Partial Body Imaging, 116053-000
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Technologist Console Interface
NEOCOIL, LLC
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
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Router Assembly
NEOCOIL, LLC
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
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Scan Room Module
NEOCOIL, LLC
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
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Sentinel P2 Audio Interface Module
NEOCOIL, LLC
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
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Sentinel P1 Audio Interface Module
NEOCOIL, LLC
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
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Sentinel S2 Audio Interface
NEOCOIL, LLC
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
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Siemens audio module
NEOCOIL, LLC
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
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PCE Pen Panel Transmitter Box
NEOCOIL, LLC
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
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Battery Charger
NEOCOIL, LLC
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
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Wireless Audio Interface
NEOCOIL, LLC
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.