Shielded Interface Unit

GUDID 07090042055024

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

Nordicneurolab AS

Medical networking interface unit
Primary Device ID07090042055024
NIH Device Record Key9fb54d7e-2ef9-409c-9fbd-f616f7f4848f
Commercial Distribution StatusIn Commercial Distribution
Brand NameShielded Interface Unit
Version Model NumberSIU 2.0
Company DUNS671280238
Company NameNordicneurolab AS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107090042055024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-28
Device Publish Date2017-05-07

Devices Manufactured by Nordicneurolab AS

07090042052122 - Visual System Power Supply 2025-04-14 Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for t
07090042052115 - Visual System HD2025-03-12 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente
07090042059084 - nordicMEDIVA2024-11-07 nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pi
07090042059077 - nordicMEDIVA2024-07-23 nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pi
07090042059053 - nordicDSC2024-02-20 nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility cont
07090042059046 - nordicDSC2022-09-21
07090042052078 - VisualSystem Power Cable (VPC)2021-02-08 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente
07090042052108 - Visual System HD2021-02-08 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente

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