mriaudio.comMRIaudio PREM System With MRIview
MRIaudio, Inc.
MRIaudio
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014680716 | 3014680716 | MRIAUDIO, INC. | 1 | N | 2026-01-01 | 5909 SEA LION PL STE F Carlsbad CA US 92010 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B66916001 | MRIaudio1600 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. | 8584270679 | support@mriaudio.com |
| B66935011 | MRIaudioPREM1001 with MRIview - 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. | 8584270679 | support@mriaudio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 218844 | 1965461501 | K193102 | MRIaudio PREM System with MRIview | LNH | 2020-01-06 |
| 218844 | 1475508908 | K180100 | MRIaudio PREM System | LNH | 2018-06-14 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LNH | 2 | 2020-01-06 |
PMN#
MRIaudio PREM System
MRIaudio
GUDID#
MRIaudioPREM1003 - The MRIaudio PREM1003 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2026-03-31
MRIaudioPREM1004 - The MRIaudio PREM1004 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2026-03-31
MRIaudioPREM1004 - The MRIaudio PREM1005 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2026-03-31
3G Transducer - 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing.
2026-03-06
MRIaudio Over-Ear Headphones - 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.
2026-03-06
MRIaudio - The MRIaudio 1507 system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2026-03-03
MRIaudioPREM1001 with MRIview - 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.
2020-01-10
MRIaudio1600 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2020-03-16
MRIaudio1400 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2020-01-30
MRIview - The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment.
2020-01-10
MRIaudioPREM1000 with MRIview - 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.
2020-01-10
MRIaudio Siemens System - MRIaudio package for Siemens. Integrates with Siemens MRI patient audio system.
2018-10-05
MRIaudioPREM1000 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2018-10-05
MRIaudioPREM1001 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2018-10-05
MRIaudioPREM1002 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2018-10-05
3G Transducer - 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing.
2018-10-01
MRIaudio1505 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2018-10-05
MRIaudio1506 - The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
2018-10-05
MRIaudio Ear-Tip - Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
2018-10-05
Wishbone Headset - MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB hearing protection and allows patients to listen to audio entertainment. Standard two prong pneumatic headphone connection. Designed for use with MRIaudio Ear-tips.
2018-10-05
MRIaudio Over-Ear Headphones - 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.
2018-10-05