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
MR Conditional FDA UDI
Category: Visual stimulator
Inroom Viewing Device by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Visual System HD — Nordicneurolab · Class II
- Coil Mounted Display — Nordicneurolab · Class II
- LCD Power Supply — Nordicneurolab · Class II
Cleared under the same submission
K092253 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 |
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Manufacturer
- Manufacturer
- Nordicneurolab
Sources (1)
- FDA UDI b1e483db-9cca-4912-b2c8-5a0a42a54ecf 35 fields · synced Jun 8, 2026