DEVICE: MRI Medium Receive Coil (00850042098035)
Device Identifier (DI) Information
MRI Medium Receive Coil
6761-M
Not in Commercial Distribution
6761-M
Promaxo, Inc.
6761-M
Not in Commercial Distribution
6761-M
Promaxo, Inc.
The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MOS | Coil, Magnetic Resonance, Specialty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
18e3d8f0-5401-4759-b6c0-25d84145bc4f
July 27, 2023
2
June 27, 2022
July 27, 2023
2
June 27, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined