FDA.reportPublic FDA data

3G Transducer

Primary DI
B6691010
Brand
3G Transducer
Company
MRIAUDIO, INC.
Model
101
Catalog number
101
Device description
3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing.
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180100000MRIaudio PREM SystemMriaudio2018-06-14LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6691010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient audiovisual communication/entertainment systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
026681280
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B66910031MRIaudioPREM1003100310032026-03-31
B66910041MRIaudioPREM1004100410042026-03-31
B66910051MRIaudioPREM1004100510052026-03-31
B6693300MRIaudio Over-Ear Headphones3303302026-03-06
B66915070MRIaudio150715072026-03-03
B66916001MRIaudio1600160016002020-03-16
B66914001MRIaudio1400140014002020-01-30
B66930001MRIview300030002020-01-10
B66935001MRIaudioPREM1000 with MRIview350035002020-01-10
B66935011MRIaudioPREM1001 with MRIview350135012020-01-10
B66910001MRIaudioPREM1000100010002018-10-05
B66910011MRIaudioPREM1001100110012018-10-05
B66910021MRIaudioPREM1002100210022018-10-05
B66910113G Transducer1011012018-10-01
B66915051MRIaudio1505150515052018-10-05
B66915061MRIaudio1506150615062018-10-05
B6693020MRIaudio Ear-Tip3023022018-10-05
B6693201Wishbone Headset3203202018-10-05
B6693301MRIaudio Over-Ear Headphones3303302018-10-05
B669SMNS00011MRIaudio Siemens SystemSMNS0001SMNS00012018-10-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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