Identity
- Trade Name
- 3G Transducer FDA UDI
- Generic Name
- Patient audiovisual communication/entertainment system FDA UDI
- Device Name
- 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing. FDA UDI
- Model / Reference
- 101 FDA UDI
- Description
- 3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing. FDA UDI
Identifiers
- Catalog Number
- 101 FDA UDI
- Primary DI / UDI-DI
- B6691011 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
3G Transducer by Mriaudio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient audiovisual communication/entertainment system.
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- 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:
- MRIaudio Ear-Tip — Mriaudio
- MRIaudio Over-Ear Headphones — Mriaudio
- MRIaudio Siemens System — Mriaudio
- MRIaudio1400 — Mriaudio
- MRIaudio1505 — 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 981367c2-6fe0-4aa4-8139-96168c029c6a 36 fields · synced May 30, 2026