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Inroom Viewing Device

FDA UDI

Class II (US FDA UDI)

by Nordicneurolab

Identity

Trade Name
Inroom Viewing Device FDA UDI
Generic Name
Visual stimulator FDA UDI
Device Name
NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, state-of-the-art solution designed specifically for use in the MR environment. LCD 40 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. LCD 40 is a 40 inch LCD (Liquid Crystal Display) monitor, compatible with MR system up to 3T. The LCD monitor uses standard DVI display signal, and can be connected to any computer or video output device with digital outputs. The LCD monitor are capable to show video signals in 4K UHD format (3840x2160 pixels) The LCD monitor is equipped with a integrated VGA camera. FDA UDI
Model / Reference
LDC 3.0 FDA UDI
Description
NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, state-of-the-art solution designed specifically for use in the MR environment. LCD 40 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. LCD 40 is a 40 inch LCD (Liquid Crystal Display) monitor, compatible with MR system up to 3T. The LCD monitor uses standard DVI display signal, and can be connected to any computer or video output device with digital outputs. The LCD monitor are capable to show video signals in 4K UHD format (3840x2160 pixels) The LCD monitor is equipped with a integrated VGA camera. FDA UDI

Identifiers

Primary DI / UDI-DI
07090042051033 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Visual stimulator

Inroom Viewing Device by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Visual stimulator.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nordicneurolab

Sources (1)

  • FDA UDI b1e483db-9cca-4912-b2c8-5a0a42a54ecf 35 fields · synced Jun 8, 2026