Search Results
Found 69 results
510(k) Data Aggregation
K Number
K223378Device Name
3.0T 16ch AIR AA
Manufacturer
GE Healthcare Coils (USA Instruments, Inc.)
Date Cleared
2023-01-03
(57 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
GE Healthcare Coils (USA Instruments, Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.
Device Description
The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.
Ask a Question
K Number
K182504Device Name
3.0T Air MP M, 3.0T Air MP L
Manufacturer
GE Healthcare Coils (USA Instruments, Inc.)
Date Cleared
2018-10-12
(30 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
GE Healthcare Coils (USA Instruments, Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0T AIR MP M is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.
The 3.0T AIR MP L is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.
Device Description
The 3.0T AIR MP M is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 20 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP M is provided with P-connectors. The coil has a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.
The 3.0T AIR MP L is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 21 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP L is provided with P-connectors. The coil has a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.
Ask a Question
K Number
K180666Device Name
48CH Head Coil
Manufacturer
GE Healthcare Coils (USA Instruments, Inc.)
Date Cleared
2018-04-12
(29 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
GE Healthcare Coils (USA Instruments, Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.
Device Description
The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.
Ask a Question
K Number
K172695Device Name
AIR Anterior Array, AIR Posterior Array
Manufacturer
GE Healthcare Coils (USA Instruments, Inc.)
Date Cleared
2017-11-22
(76 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
GE Healthcare Coils (USA Instruments, Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. The nucleus detected is hydrogen.
The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. The nucleus detected is hydrogen.
Device Description
The AIR Anterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone. The AIR Anterior Array contains 30 elements and the housing of the AIR Anterior Array is made of a soft, pliable material that conforms to the patient's anatomy. The coil is padded with a soft material designed to maximize patient comfort.
The AIR Posterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the spine, abdomen, torso, pelvis, prostate, cardiac, hips and long bone. The AIR Posterior Array contains 60 elements and is embedded within the patient table of the MR System.
Ask a Question
K Number
K163205Device Name
48CH Head Coil
Manufacturer
GE Healthcare Coils (USA Instruments, Inc.)
Date Cleared
2017-01-12
(58 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
GE Healthcare Coils (USA Instruments, Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.
Device Description
The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality and a custom MEMS (Micro Electro Mechanical System) switch to decouple the receive coil from the MR System body coil. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.
Ask a Question
K Number
K052916Device Name
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
Manufacturer
USA INSTRUMENTS, INC.
Date Cleared
2005-11-09
(23 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
USA INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.
The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.
Device Description
The 3.0T 16 Channel Brain Spine () Array Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
Ask a Question
K Number
K052584Device Name
1.5T 12 CHANNEL BODY ARRAY
Manufacturer
USA INSTRUMENTS, INC.
Date Cleared
2005-10-07
(17 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
USA INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
Device Description
The USA Instruments 1.5T 12 Channel Torso Coil is a 12- element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. This coil designed for use with the 1.5T Signa Excite MRI scanner, manufactured by General Electric Healthcare. The coil will be available with different connector configurations depending on the configuration of the scanner it will be used with.
Ask a Question
K Number
K052621Device Name
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
Manufacturer
USA INSTRUMENTS, INC.
Date Cleared
2005-10-07
(14 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
USA INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen. The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI systems manufactured by GE Medical Systems.
Device Description
The 1.5T Brain / Spine Array Coil is a receive-only RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine in GE 1.5T MR Imaging systems.
The open design of the 1.5T Brain / Spine Array Coil reduces claustrophobic effects and allows for increased patient comfort. The coil elements are enclosed in a rigid plastic housing. The housing is designed to conform to the patient anatomy. The design of the coil allows for easy positioning of the patient and provides patient comfort.
The mechanical housing of 1.5T Brain / Spine Array Coil consists of four main parts: (1) a main head coil base, (2) a split-top head coil housing (3) a chest coil housing and (4) a T-L Spine housing. The chest coil housing is free floating and it rests on the patient's chest.
The 1.5T Brain / Spine Array Coil has an array of 21 coil elements in the Brain Unit and 8 coil elements in the Spine Unit; The 21 coil elements in the brain unit are Loop elements. Twelve loop coils (L1 to L12) cover the head region. Another four loop coils (L13 to L16) cover the Lower neck and torso regions. Five Loop coils (L17 to L21) cover the upper neck and the chest region. The Spine Unit has an array of four loop coils and four saddle coils which cover the thoracic and lumbar spine regions.
For operation, the 1.5T Brain / Spine Array Coil does not require any change to the software used on the GE Medical Systems Inc. 1.5T MRI system.
Ask a Question
K Number
K052585Device Name
3T HD BREAST ARRAY
Manufacturer
USA INSTRUMENTS, INC.
Date Cleared
2005-10-04
(14 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
USA INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0T HD Breast Array is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.
Device Description
The 3.0T HD Breast Array is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The 3.0T HD Breast Array is designed to offer optimized imaging capabilities and maximum lateral and medial access to each breast for biopsy procedures.
Ask a Question
K Number
K050728Device Name
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
Manufacturer
USA INSTRUMENTS, INC.
Date Cleared
2005-06-28
(99 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
USA INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Open Breast Coil with Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Open Breast Coil with Biopsy Plates is designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System.
The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Device Description
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Open Breast coil with Biopsy plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
Ask a Question
Page 1 of 7