DEVICE: 3G Transducer (B6691011)

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Device Record History
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Device Identifier (DI) Information
3G Transducer
101
Not in Commercial Distribution
101
MRIAUDIO, INC.
B6691011
HIBCC
March 06, 2026
1
026681280 *Terms of Use
3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing.
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Device Characteristics
MR Conditional
No
No
No
No
No
No
No
No

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?
64404 Patient audiovisual communication/entertainment system
An assembly of devices intended to be used to provide a communication and/or entertainment channel for a patient undergoing a radiological examination (e.g., MRI scan). It typically consists of a control unit, intercom, and data communication hub; with earplugs, or other personal audio device, and/or a visual monitor for the patient. It may be supplied in a modular fashion.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LNH System, Nuclear Magnetic Resonance Imaging
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K180100 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
981367c2-6fe0-4aa4-8139-96168c029c6a
March 09, 2026
3
October 01, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
8584270679
support@mriaudio.com
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