FDA.reportPublic FDA data

MRIaudioPREM1003

Primary DI
B66910031
Brand
MRIaudioPREM1003
Company
MRIAUDIO, INC.
Model
1003
Catalog number
1003
Device description
The MRIaudio PREM1003 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
Published
2026-03-31
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
B66910031PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
026681280
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B6693301MRIaudio Over-Ear Headphones3303302018-10-05
B669SMNS00011MRIaudio Siemens SystemSMNS0001SMNS00012018-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
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
B66910041MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
B66910051MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
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10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
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10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
00195278601162NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDLNH2025-04-15
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
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10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19
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