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510(k) Data Aggregation
K Number
K243209Device Name
nordicMEDiVA
Manufacturer
NordicNeurolab AS
Date Cleared
2024-10-22
(21 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NordicNeurolab AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The nordicMEDIVA software is an advanced visualization and processing platform with a specific focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain. The software runs on a server in a networked environment and is accessed by users via a standard web browser. It can communicate with other imaging platforms that support DICOM, and process medical image data acquired through DICOM-compliant imaging devices and modalities.
nordicMEDIVA is indicated for image analysis and visualization of functional and dynamic MRI data of the brain, presenting derived properties and parameters from the input image data in a clinically useful context.
Device Description
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 NordiclmagingLab 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 Al algorithms based on neural networks. The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
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K Number
K241608Device Name
nordicMEDiVA
Manufacturer
NordicNeuroLab AS
Date Cleared
2024-06-28
(24 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NordicNeuroLab AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The nordicMEDiVA software is an advanced visualization and processing platform with a specific focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain. The software runs on a server in a networked environment and is accessed by users via a standard web browser. It can communicate with other imaging platforms that support DICOM, and process medical image data acquired through DICOM-compliant imaging devices and modalities.
nordicMEDiVA is indicated for image analysis and visualization of functional and dynamic MRI data of the brain, presenting derived properties and parameters from the input image data in a clinically useful context.
Device Description
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 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.
The following modules provide the main functions of the device.
nordicView: A browser-based user interface accessed from desktop clients that provides tools for general image visualization, export, and relevant analysis tools for BOLD-fMRI and DSC-perfusion.
nordicBOLD: BOLD task-based fMRI anall magnetic susceptibility changes in the human brain in areas with altered blood flow resulting from neuronal activity. The image processing requires the definition of a so-called design matrix which is used to calculate voxel-wise statistics conveying information about the probability of the execution of the qiven task.
The design matrix is is defined such that the task or stimulation that was presented to the patient during the scan. The task or stimulation presented during scan time is often refered to as "the paradigm". The design matrix can be defined manually by the user, or a paradigm from nordicAktiva - another product from NordicNeuroLab - can be used.
nordicAktiva is a software, marketed by NordicNeuroLab, that may be used during scan time to present the patient or subject being scanned. The use of nordicAktiva is not required.
nordicDSC: Calculations of perfusion-related parameters that provide information about the blood vessel structure and characteristics. Such maps include blood volume, blood flow, time to peak, mean transit time, and leakage.
Platform: The platform includes a database, DICOM functionality, various APls, processing pipelines for the medical image analysis modules. Serves as a backbone component for the other modules of nordicMEDiVA.
Dashboard: a browser-based user interface accessed from desktop clients for administration and configuration.
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K Number
K232680Device Name
fMRI Hardware System
Manufacturer
NordicNeuroLab AS
Date Cleared
2023-12-13
(103 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
NordicNeuroLab AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR maging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
Device Description
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR imaging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, ResponseGrip, SyncBox and nordicAktiva.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is primarily used for determining which area of the brain is responsible for specific processes controlling essential functions such as movement, speech, hearing, and vision. This information can form part of the pre-operative planning process in patients with brain tumors, for example. Functional MRI can also be used for research into specific neurological conditions or investigating cognitive function and networks in general.
The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and auditory stimulation is critical to make sure that the correct MR image of the activated brain is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.
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K Number
K212720Device Name
nordicDSC
Manufacturer
NordicNeurolab AS
Date Cleared
2022-03-03
(188 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NordicNeurolab AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
nordicDSC is a medical image post-processing software for the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain to be used by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications.
The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, receiving, and viewing of data, data quality control, and connection to network.
Device Description
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 as a plugin to a DICOM handling platform.
The program functionality can be divided into three main categories:
1. Accessing image data
2. MR image processing and analysis
3. Generating output, including information regarding blood flow, time to peak, and leakage.
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K Number
K191032Device Name
fMRI Hardware System
Manufacturer
NordicNeurolab AS
Date Cleared
2019-11-27
(223 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
NordicNeurolab AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
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 [VisualSystem HD] or by an in-room LCD monitor.
Device Description
The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is useful when determining certain diseases, gaining more information about a patient's condition or investigating cognitive functions. The technique is also used for examining the area of the brain affected in patients suffering from a brain tumor in both the pre-operative and post-operative stages.
The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and audio stimulation is critical to make sure that the correct MR image of the brains activity is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.
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K Number
K163324Device Name
nordicBrainEx
Manufacturer
NordicNeurolab AS
Date Cleared
2017-01-27
(63 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NordicNeurolab AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Device Description
The nordicBrainEx is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application.
- . BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human 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 of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain.
- . DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage.
- DCE Perfusion analysis: Enables analysis of Dynamic Contrast Enhancement (DCE) MR data. In contrast to DSC Perfusion which uses T2* weighted sequence, DCE Perfusion uses T1-weighted sequence to measure bolus passage. Parameters are calculated to provide information about blood vessel structure and characteristics. The output maps from these calculations include interstitial volume (Ve), plasma volume (Vp), transfer constant map (Ktras), rate constant map (Kep), area under the curve (AUC), time to peak (TTP), peak, wash In and wash Out.
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 the application is optimized to ensure efficiency and high throughput in a clinical environment.
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