Identity
- Trade Name
- MRIaudio1505 FDA UDI
- Generic Name
- Patient audiovisual communication/entertainment system FDA UDI
- Device Name
- The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. FDA UDI
- Model / Reference
- 1505 FDA UDI
- Description
- The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. FDA UDI
Identifiers
- Catalog Number
- 1505 FDA UDI
- Primary DI / UDI-DI
- B66915051 FDA UDI
- 510(k) Number
- K180100 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Patient audiovisual communication/entertainment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Patient audiovisual communication/entertainment system
MRIaudio1505 by Mriaudio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient audiovisual communication/entertainment system.
- Silent Scan — Avotec, Inc. · Class II
- Silent Scan — Avotec, Inc. · Class II
- MOC — Optoacoustics, Ltd. · Class II
- Innovision — Innovere Medical, Inc. · Class II
- Silent Scan — Avotec, Inc. · Class II
- Innovision — Innovere Medical, Inc. · Class I
- Silent Scan — Avotec, Inc. · Class II
- CinemaVision — RESONANCE TECHNOLOGY, INC. · Class II
Cleared under the same submission
K180100 also covers:
- 3G Transducer — Mriaudio
- MRIaudio Ear-Tip — Mriaudio
- MRIaudio Over-Ear Headphones — Mriaudio
- MRIaudio Siemens System — Mriaudio
- MRIaudio1400 — Mriaudio
- MRIaudio1506 — Mriaudio
- MRIaudio1600 — Mriaudio
- MRIaudioPREM1000 — Mriaudio
- MRIaudioPREM1001 — Mriaudio
- MRIaudioPREM1002 — Mriaudio
- Wishbone Headset — Mriaudio
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mriaudio
Sources (1)
- FDA UDI 2c8773e1-0bbe-46ba-b8d8-9bf2d8a0a15e 36 fields · synced Jun 6, 2026