Technologist Console Interface

FDA UDI

Class II (US FDA UDI)

by Neocoil, Llc

Identity

Trade Name: Technologist Console Interface 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: 80 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: 00856181003800 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Headphones

Technologist Console Interface 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
Wireless Audio Interface — NEOCOIL, LLC · Class II
Router Assembly — 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

K173409 also covers:

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 a0600c08-23a3-4924-8195-b801ba24e527 34 fields · synced May 30, 2026