DEVICE: Coil Mounted Display (07090042052016)
Device Identifier (DI) Information
Coil Mounted Display
CMD 2.3
In Commercial Distribution
Nordicneurolab AS
CMD 2.3
In Commercial Distribution
Nordicneurolab AS
Coil Mounted Display 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.
Coil Mounted Display is a flexible solution for presenting visual stimuli inside the MR scanner, which is based on OLED technology.
Device Characteristics
MR Conditional | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35373 | Visual stimulator |
An electronic device used to apply visual stimuli (e.g., shifting patterns of light) to a patient's eyes. This device typically presents light to the eye through an optical system (optical stimulator), or light is viewed directly from an illuminated screen (direct-view stimulator), or light-emitting diode (LED) stimulating goggles. It is typically used as a component of several other devices such as refractors, scanning ophthalmoscopes, visual evoked potential (VEP) recording systems, or an electroretinograph (ERG).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LNH | System, Nuclear Magnetic Resonance Imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K092253 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6fe320cc-5977-4b47-b3e8-280dff12822c
June 02, 2020
5
September 24, 2016
June 02, 2020
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4755707095
ProductSolutions@nordicneurolab.com
ProductSolutions@nordicneurolab.com