FDA.reportPublic FDA data

NORDICNEUROLAB AS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30067384483006738448NORDICNEUROLAB AS1N2026-01-01MOLLENDALSVEIEN 1 BERGEN Hordaland NO 5009

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07090042052078VisualSystem 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)+4955707095ProductSolutions@nordicneurolab.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
680021929732060K251937nordicAudio (1.0)LNH2026-03-20
680021707636176K243209nordicMEDiVALLZ2024-10-22
680021436718420K241608nordicMEDiVALLZ2024-06-28
680021951767652K232680fMRI Hardware SystemLNH2023-12-13
680021903497874K212720nordicDSCLLZ2022-03-03
680021463107505K191032fMRI Hardware SystemLNH2019-11-27
680021010474636K163324nordicBrainExLLZ2017-01-27
680021900804325K092253MODIFICATION TO FMRI HARDWARE SYSTEMLNH2009-10-08
680021287831866K090546MODIFICATION TO NORDICICE SOFTWARELLZ2009-06-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ52024-10-22
LNH42026-03-20

PMN#

GUDID#

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.

Nordicneurolab AS

2019-10-24

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.

Nordicneurolab AS

2016-09-24

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.

Nordicneurolab AS

2016-09-24

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

Nordicneurolab AS

2017-05-07

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.

Nordicneurolab AS

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, 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.

Nordicneurolab AS

2024-07-15

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.

Nordicneurolab AS

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.

Nordicneurolab AS

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.

Nordicneurolab AS

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.

Nordicneurolab AS

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.

Nordicneurolab AS

2020-06-01

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.

Nordicneurolab AS

2016-10-24