MRIaudio 1507

GUDID B66915070

The MRIaudio 1507 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.

MRIAUDIO, INC.

Patient audiovisual communication/entertainment system

• Primary Device ID: B66915070
• NIH Device Record Key: 0b4628cf-5255-43de-b6de-c72a96f430ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRIaudio
• Version Model Number: 1507
• Catalog Number: 1507
• Company DUNS: 026681280
• Company Name: MRIAUDIO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B66915070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180100

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-11
• Device Publish Date: 2026-03-03

Devices Manufactured by MRIAUDIO, INC.

• B66915070 - MRIaudio: 2026-03-11The MRIaudio 1507 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
• B66915070 - MRIaudio: 2026-03-11 The MRIaudio 1507 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66916001 - MRIaudio1600: 2020-03-24 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66914001 - MRIaudio1400: 2020-02-07 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66930001 - MRIview: 2020-01-20 The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment.
• B66935001 - MRIaudioPREM1000 with MRIview: 2020-01-20 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visu
• B66935011 - MRIaudioPREM1001 with MRIview: 2020-01-20 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visu
• B66910001 - MRIaudioPREM1000: 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h
• B66910011 - MRIaudioPREM1001: 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h