FDA.reportPublic FDA data

MRIaudioPREM1000 with MRIview

Primary DI
B66935001
Brand
MRIaudioPREM1000 with MRIview
Company
MRIAUDIO, INC.
Model
3500
Catalog number
3500
Device description
The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
Published
2020-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
K193102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193102000MRIaudio PREM System with MRIviewMriaudio, Inc.2020-01-06LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B66935001PrimaryHIBCC0

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

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
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
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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
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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
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