Coil Mounted Display

FDA UDI

Class II (US FDA UDI)

by Nordicneurolab

Identity

Trade Name: Coil Mounted Display FDA UDI
Generic Name: Visual stimulator FDA UDI
Device Name: Coil Mounted Display is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor. Coil Mounted Display is a flexible solution for presenting visual stimuli inside the MR scanner, which is based on OLED technology. FDA UDI
Model / Reference: CMD 2.3 FDA UDI
Description: Coil Mounted Display is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor. Coil Mounted Display is a flexible solution for presenting visual stimuli inside the MR scanner, which is based on OLED technology. FDA UDI

Identifiers

Primary DI / UDI-DI: 07090042052016 FDA UDI
510(k) Number: K092253 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Visual stimulator 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

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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Visual stimulator

Coil Mounted Display by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Visual Stimulation Box — Intelligent Hearing Systems Corp. · Class II
Flash Led Stimulator — EB NEURO SPA · Class II
Visual System HD — Nordicneurolab · Class II
LCD Power Supply — Nordicneurolab · Class II
LCD Power Supply — Nordicneurolab · Class II

Cleared under the same submission

K092253 also covers:

CommunicationConsole — Nordicneurolab
Eye Tracker Camera — Nordicneurolab
Fiberlink transmitter — Nordicneurolab
Headphones — Nordicneurolab
Inroom Viewing Device — Nordicneurolab
LCD Power Supply — Nordicneurolab
LCD Power Supply — Nordicneurolab
Shielded Interface Unit — Nordicneurolab

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

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Manufacturer

Manufacturer: Nordicneurolab

Sources (1)

FDA UDI 6fe320cc-5977-4b47-b3e8-280dff12822c 35 fields · synced May 30, 2026