Duns Number:671280238
Device Description: Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System.SIU is a shielded en 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
Catalog Number
-
Brand Name
Shielded Interface Unit
Version/Model Number
SIU 2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092253
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
9fb54d7e-2ef9-409c-9fbd-f616f7f4848f
Public Version Date
November 10, 2021
Public Version Number
7
DI Record Publish Date
May 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |