Shielded Interface Unit

FDA UDI

Class II (US FDA UDI)

by Nordicneurolab

Identity

Trade Name: Shielded Interface Unit FDA UDI
Generic Name: Medical networking interface unit FDA UDI
Device Name: Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System. SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System. SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system FDA UDI
Model / Reference: SIU 2.0 FDA UDI
Description: Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System. SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System. SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system FDA UDI

Identifiers

Primary DI / UDI-DI: 07090042055024 FDA UDI
510(k) Number: K092253 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Medical networking interface unit 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: Medical networking interface unit

Shielded Interface Unit by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 9fb54d7e-2ef9-409c-9fbd-f616f7f4848f 35 fields · synced Jun 8, 2026