Search Results
Found 6 results
510(k) Data Aggregation
K Number
K173290Device Name
DuoFLEX Coil Suite
Manufacturer
Date Cleared
2017-11-28
(43 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MR Instruments, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 1.5T GE and Siemens DuoFLEX® Coil Suites and the 3.0T GE and Siemens DuoFLEX® Coil Suites are indicated for use on the order of a physician in conjunction with a 1.5T GE Healthcare and Siemens Healthcare Magnetic Resonance Scanner system and a 3.0T GE Healthcare and Siemens Healthcare Magnetic Resonance Scanner system to produce 2D and 3D images that when interpreted by a trained physician vield information that may assist in diagnosis.
Device Description
The MR Instruments FC 1520G-8R, FC 3000G-8R, FC 1500S-8R, and FC 3000S-8R Coil Suites are identical with the only exceptions:
FC 1520G-8R (GE MR Systems @ 63.86MHz with GE System Connector Plug)
FC 3000G-8R (GE MR Systems @ 127.73MHz with GE System Connector Plug)
FC 1500S-8R (Siemens MR Systems @ 63.6MHz with Siemens System Connector Plug)
FC 3000S-8R (Siemens MR Systems @ 123.23MHz with Siemens System Connector Plug)
The coil suites include two different sets of coil paddles and a single, shared preamplifier box (the "Connector Box") with a system connector. One set contains a pair of coil paddles containing four 24cm loops/channels per paddle for a total of eight channels for the two paddles. The second set contains a pair of coil paddles containing four 10cm loops/channels per paddle for a total of eight channels for the two paddles. These paddles connect to the same connector box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in the following configurations:
24cm by itself
24cm with 24cm
24cm with 10cm
10cm with 10cm
The aforementioned configurations provide 4 or 8 channels for imaging.
Ask a Question
Ask a specific question about this device
K Number
K130706Device Name
DUOFLEX COIL SUITE (1.5T)
Manufacturer
Date Cleared
2013-07-25
(132 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MR INSTRUMENTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.
Device Description
The MR Instruments FC1500G-8R DuoFLEX® Coil Suite includes three different sets of coil paddles and a single, shared preamplifier box (the "Connector Box") with a system connector. One set of coil paddles is a pair of 24cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The second set of paddles is a pair of 10cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The third set of paddles is a single rectangular, interventional coil containing a single planar loop. All of these paddles connect to the same connector box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 1, 5 or 8 channels for imaging.
Ask a Question
Ask a specific question about this device
K Number
K110591Device Name
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
Manufacturer
Date Cleared
2011-03-29
(27 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MR INSTRUMENTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This coil is indicated for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic Resonance Scanner systems to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are multi-channel receive only coils consisting of 16 RF elements. Each RF element has active and passive blocking networks, and integrated preamplifiers. The MC 1504G-16R RF elements are tuned to 'H at 1.5T (63.9 MHz), while the MC 3004G-16R RF elements are tuned to 'H at 3.0T (127.8 MHz). The coil housing is constructed out of a rigid plastic with an opening for patient viewing and comfort; the head support/base is included with each coil assembly.
Ask a Question
Ask a specific question about this device
K Number
K080820Device Name
TEM 3002G- HN DUAL TUNE HEAD COIL
Manufacturer
Date Cleared
2008-04-02
(9 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MR INSTRUMENTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (20Na) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis. This device is for prescription use.
Device Description
The TEM 3002G-HN Dual Tune headcoil is a quadrature transmit/receive RF coil tuned to proton ('H) and sodium (22Na) frequencies 3T. The TEM resonant elements and associated matching and quadrature splitting circuitry are enclosed in a rigid plastic housing to prevent any exposure to patient or environment.
Ask a Question
Ask a specific question about this device
K Number
K072931Device Name
MC 3003G-32R HEAD COIL
Manufacturer
Date Cleared
2007-10-30
(14 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MR INSTRUMENTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
Ask a Question
Ask a specific question about this device
K Number
K040937Device Name
TEM 3000 HEAD COIL
Manufacturer
Date Cleared
2004-04-23
(11 days)
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MR INSTRUMENTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is compatible with the 3T Magnetom Trio MR scanner manufactured by Siemens Medical Systems.
Device Description
The TEM 3000 Head Coil is a 15-element quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent any exposure to patient or environment. The coil housing employs a large open viewing window on the top. The coil design facilitates the scanning of patients with different window on the top: "Ifizes patient comfort and ease of use. Included with the coil housing is a Head Support/Coil Base. It allows the coil to be slid back for better patient access.
Ask a Question
Ask a specific question about this device
Page 1 of 1