Identity
- Trade Name
- Router Assembly FDA UDI
- Generic Name
- Headphones FDA UDI
- Device Name
- The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals. The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure. FDA UDI
- Model / Reference
- 79 FDA UDI
- Description
- The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals. The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003794 FDA UDI
- 510(k) Number
- K173409 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Headphones 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Headphones
Router Assembly by Neocoil, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Headphones.
- MRIaudio Over-Ear Headphones — Mriaudio · Class II
- Wishbone Headset — Mriaudio · Class II
- MRIaudio Ear-Tip — Mriaudio · Class II
- Battery Charger — NEOCOIL, LLC · Class II
- Technologist Console Interface — NEOCOIL, LLC · Class II
- Wireless Audio Interface — NEOCOIL, LLC · Class II
- Stand-Alone Wireless Audio Headphones — NEOCOIL, LLC · Class II
- Pen Panel Transmitter Box — NEOCOIL, LLC · Class II
Cleared under the same submission
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
- Neocoil, Llc
Sources (1)
- FDA UDI b457568a-23c7-4fec-ad27-9523368abacd 34 fields · synced Jun 6, 2026