Duns Number:671280238
Device Description: NordicNeuroLab’s LCD monitor (NNL MRI InroomViewingDevice LCD 40) is a complete, state-of- 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.
Catalog Number
-
Brand Name
Inroom Viewing Device
Version/Model Number
LDC 3.0
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"
-
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
b1e483db-9cca-4912-b2c8-5a0a42a54ecf
Public Version Date
June 02, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 |