DEVICE: DuoFLEX® Coil Suite (00857371006304)

Device Identifier (DI) Information

DuoFLEX® Coil Suite
FC3000S-8R
In Commercial Distribution
40-00281-001
M R Instruments, Inc.
00857371006304
GS1

1
112719096 *Terms of Use
The 24cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000S-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier 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 4 or 8 channels for imaging.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40749 MRI system coil, radio-frequency
A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.
Active false
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FDA Product Code

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Product Code Product Code Name
MOS Coil, Magnetic Resonance, Specialty
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K173290 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f6aca865-93a2-488b-a77a-0db07770fdd4
March 18, 2022
1
March 10, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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No Customer Contact currently defined
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