nordicneurolab.comnordicMEDiVA
Nordicneurolab AS
NORDICNEUROLAB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006738448 | 3006738448 | NORDICNEUROLAB AS | 1 | N | 2026-01-01 | MOLLENDALSVEIEN 1 BERGEN Hordaland NO 5009 |
| 3007319065 | 3007319065 | NordicNeuroLab INC. | 1 | Y | 2026-01-01 | 234 W FLORIDA ST STE 202 Milwaukee WI US 53204 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07090042051040 | LCD Power Supply - LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD Monitor Shielded enclosure containing the Power Supply Unit for the LCD Monitor which is located in the MR environment. LPS 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. | +4755707095 | ProductSolutions@nordicneurolab.com |
| 07090042052016 | Coil Mounted Display - 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. | +4755707095 | ProductSolutions@nordicneurolab.com |
| 07090042052023 | Eye Tracker Camera - ETC 2.0 | +4755707095 | customerservice@nordicneurolab.com |
| 07090042053013 | Headphones - Head Phones is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone is designed specifically for use in the MR environment, and are compatible with MR system up to 3T. | +4755707095 | ProductSolutions@nordicneurolab.com |
| 07090042053044 | CommunicationConsole - CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. | +4755707095 | ProductSolutions@nordicneurolab.com |
| 07090042055017 | Fiberlink transmitter - Fiberlink transmitter is part of NordicNeuroLab’s fMRI System. Fiberlink transmitter converts audio and video signals into an optical signal for transmission. Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System. | +4755707095 | ProductSolutions@nordicneurolab.com |
| 07090042055024 | Shielded Interface Unit - 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 | +4755707095 | ProductSolutions@nordicneurolab.com |
| 07090042059022 | nordicAktiva - NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient. | +4755707095 | ProductSolutions@nordicneurolab.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 68002 | 1929732060 | K251937 | nordicAudio (1.0) | LNH | 2026-03-20 |
| 68002 | 1707636176 | K243209 | nordicMEDiVA | LLZ | 2024-10-22 |
| 68002 | 1436718420 | K241608 | nordicMEDiVA | LLZ | 2024-06-28 |
| 68002 | 1951767652 | K232680 | fMRI Hardware System | LNH | 2023-12-13 |
| 68002 | 1903497874 | K212720 | nordicDSC | LLZ | 2022-03-03 |
| 68002 | 1463107505 | K191032 | fMRI Hardware System | LNH | 2019-11-27 |
| 88958 | 1463107505 | K191032 | fMRI Hardware System | LNH | 2019-11-27 |
| 68002 | 1010474636 | K163324 | nordicBrainEx | LLZ | 2017-01-27 |
| 68002 | 1900804325 | K092253 | MODIFICATION TO FMRI HARDWARE SYSTEM | LNH | 2009-10-08 |
| 68002 | 1287831866 | K090546 | MODIFICATION TO NORDICICE SOFTWARE | LLZ | 2009-06-08 |
Product Codes Associated With Registrations#
PMN#
nordicMEDiVA
Nordicneurolab AS
fMRI Hardware System
Nordicneurolab AS
NordicDSC
NordicNeurolab AS
FMRI Hardware System
NordicNeurolab AS
NordicBrainEx
NordicNeurolab AS
LCD MONITOR
NORDICNEUROLAB
NORDICBRAINEX
NORDICNEUROLAB
NORDIC TUMOREX
NORDICNEUROLAB
MODIFICATION TO FMRI HARDWARE SYSTEM
NORDICNEUROLAB
FMRI HARDWARE SYSTEM
NORDICNEUROLAB
FMRI HARDWARE SYSTEM
NORDICNEUROLAB
GUDID#
nordicAktiva - NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
2017-05-22
Shielded Interface Unit - 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
2017-05-07
Fiberlink transmitter - Fiberlink transmitter is part of NordicNeuroLab’s fMRI System. Fiberlink transmitter converts audio and video signals into an optical signal for transmission. Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System.
2016-09-24
CommunicationConsole - CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.
2016-10-24
Headphones - Head Phones is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone. The Head Phone is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
2016-09-24
Eye Tracker Camera - ETC 2.0
2017-12-31
Coil Mounted Display - 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.
2016-09-24
LCD Power Supply - LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD Monitor Shielded enclosure containing the Power Supply Unit for the LCD Monitor which is located in the MR environment. LPS 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.
2016-09-24
Inroom Viewing Device - 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.
2016-09-24
LCD Power Supply - LCD Power Supply (LPS) for NordicNeuroLab’s 40inch LCD Monitor Shielded enclosure containing the Power Supply Unit for the LCD Monitor which is located in the MR environment. LPS 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.
2019-06-27
SyncBox - SynkBox is part of NordicNeuroLab’s fMRI System. The SyncBox is connected directly to the MRI scanner where it receives timing pulses sent out with each image series and demodulates this signal before it’s forwarded to the stimulus PC. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings.
2019-10-24
ResponseGrip Interface - ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PC The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
2019-10-24
Visual System Power Supply - Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. 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.
2020-03-01
Visual System HD - The VisualSystem HD 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 (Visual System HD)
2020-03-01
Control Room Interface - Control Room Interface (CRI) is part of Visual System HD. CRI is the interface unit for video signal in (HDMI) and eye tracking video out (HDMI). 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, Visual System HD.
2020-03-01
Visual System HD - The VisualSystem HD 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 (Visual System HD)
2021-01-29
VisualSystem Power Cable (VPC) - The VisualSystem HD 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 (Visual System HD) The VisualSystem Power Cable (VPC) provides connection between the VisualSystem Power Supply (VPS) And the coil mounted displays (VHD)
2021-01-29
nordicDSC - nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed on the nordicMEDiVA platform, or as a plugin to other software offerings.
2024-02-12
Visual System Power Supply - Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. 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.
2025-04-04
AudioHub - nordicAudio is an audio system for use in MR. The AudioHub is placed in the operator room and provides a connection point for various audio sources.
2026-04-01
AccessPoint - nordicAudio is an audio system for use in MR. The AccessPoint is placed in the MR-room. It is connected to the AudioHub in the operator room via a fiber connection and provides a connection point in the MR room for the fiber cable from the HeadSet.
2026-04-01
BatteryCharger - nordicAudio is an audio system for use in MR. The BatteryCharger is a charger for the MR compatible BatteryBox. The Charger itself is MR unsafe.
2026-04-01
HeadSet 3T - nordicAudio is an audio system for use in MR, consisting of a HeadSet with BatteryBox and an AccessPoint in the MR Room. An AudioHub and a BatteryCharger is placed in the operator room.
2026-04-01
BatteryBox - nordicAudio is an audio system for use in MR. The BatteryBox contains a rechargeable battery for the headset.
2026-04-01
HeadSet 1,5T - nordicAudio is an audio system for use in MR. The HeadSet is an MR compatible Headset to play audio during MR examination.
2026-04-01
nordicDSC - 1.1
2022-09-13
nordicMEDIVA - nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure.The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data.The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
2024-07-15
Visual System HD - The VisualSystem HD 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 (Visual System HD)
2025-03-04
ResponseGrips - The ResponseGrip is an MRI-safe patient response device, providing real-time feedback of a patient response. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
2017-05-22
nordicMEDIVA - nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware or in their own cloud infrastructure.The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data.The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
2024-10-30
nordicAktiva - NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
2024-01-10
nordicBrainEx - The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focuson ease of use and high performance on a standard Windows workstation. The software providescomprehensive functionality for dynamic image analysis and visualization of MRI data, where signalchanges over time are analyzed to determine various modality dependent functional parameters. Thefollowing algorithms provide the main functional analyses of the application.- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in thehuman brain in areas with altered blood-flow resulting from neuronal activity.- DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis ofdiffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusionto display the white matter structure in the brain.- DSC: Calculations of perfusion related parameters that provide information about the bloodvessel structure and characteristics. Examples of such maps are blood volume, blood flow, timeto peak, mean transit time and leakage.In addition to these specific functional analyses, the application also provides general visualization tools,a database for data handling, and a reporting feature. This is to ensure that the workflow of theapplication is optimized to ensure efficiency and high throughput in a clinical environment.
2017-05-07
ResponseGrip Interface - ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PCThe ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
2017-05-22
Inroom Viewing Device - 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 HDMI 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 an integrated VGA camera.
2020-06-01
SyncBox - SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directly to the MRI scanner where it receives timing pulses sent out with each image series and demodulates this signal before it’s forwarded to the stimulus PC. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings.
2016-10-24
HeadPhones Slim - Head Phones Slim is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
2016-10-24