FDA.reportPublic FDA data

MRIaudio Over-Ear Headphones

Primary DI
B6693301
Brand
MRIaudio Over-Ear Headphones
Company
MRIAUDIO, INC.
Model
330
Catalog number
330
Device description
MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection.
Published
2018-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Contact Domains#

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
B6693301PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
HeadphonesA device that is worn on the head, typically fitting over both ears, but that may fit over one ear. It supplies the user with audio input increasing the sound volume of, e.g., television, radio, or a communication amplifier.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8584270679support@mriaudio.com

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
B66910103G Transducer1011012026-03-06
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
B669SMNS00011MRIaudio Siemens SystemSMNS0001SMNS00012018-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
B66910031MRIaudioPREM1003MRIAUDIO, INC.LNH2026-03-31
B66910041MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
B66910051MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
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