Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
nordicMEDiVA
NordicNeurolab AS
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. Intended users nordicMEDiVA must be operated according to its intended purpose and only by qualified medical personnel with the necessary knowledge in accordance with country-specific regulations, such as trained radiological technicians or physicians. Users must have received training in applicable areas, such as in MR technology and neuroanatomy. Contraindications The software is not be used as an archiving device for patients' image data. Indications for use 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. The software is not to be used as a sole basis for clinical decisions, but further evidence has to be taken into account. The software is not to be used as a sole basis in emergency care applications. The software is not to be used for applications other than the analysis and visualization of MR data, or data derived thereof, of the human brain. Patient target population nordicMEDiVA has no limitation concerning the patient population.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- 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. Intended users nordicMEDiVA must be operated according to its intended purpose and only by qualified medical personnel with the necessary knowledge in accordance with country-specific regulations, such as trained radiological technicians or physicians. Users must have received training in applicable areas, such as in MR technology and neuroanatomy. Contraindications The software is not be used as an archiving device for patients' image data. Indications for use 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. The software is not to be used as a sole basis for clinical decisions, but further evidence has to be taken into account. The software is not to be used as a sole basis in emergency care applications. The software is not to be used for applications other than the analysis and visualization of MR data, or data derived thereof, of the human brain. Patient target population nordicMEDiVA has no limitation concerning the patient population.
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
- Intended users
- Qualified medical personnel
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult and Pediatric
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Post-processing analysis
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- MR images or data. Inclusion criteria: Functional and dynamic MRI data of the brain acquired through DICOM-compliant imaging devices and modalities, including BOLD-fMRI, diffusion-weighted MRI, and DSC-perfusion MRI data.
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- The device outputs derived properties and parameters from functional and dynamic MRI data of the brain, including: BOLD task-based fMRI activation maps (voxel-wise statistics indicating probability of voxel involvement in task execution); diffusion tensor imaging (DTI) derived maps such as fractional anisotropy (FA) and mean diffusivity (MD); 3D tractography reconstructions of major white matter pathways; DSC-perfusion maps including blood volume, blood flow, time to peak, mean transit time, and leakage. Results can be exported to PACS, neuro navigation systems, or other DICOM-compliant modalities.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Research pending
Confirm contraindications, unsupported populations, scanners, protocols, and known failure modes.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
- FDA submission
- K243209
- Modality
- MRI
Imaging modality reported in the exact-submission ACR AI Central model card.
- Anatomy
- Brain
Anatomy normalized from explicit exact-submission ACR model-card wording.
- Clearance type
- 510(k)
- Decision date
- 2024-10-22
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM and PACS in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- Hybrid
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- Study type: Stand-Alone Performance
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
nordicMEDiVA regulatory performance study summary
Stand-Alone Performance · Adult and Pediatric
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K243209 · Independence not establishedK243209
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Economics and lifecycle
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify limitations: Confirm contraindications, unsupported populations, scanners, protocols, and known failure modes.
- Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-02Last searched
17Fields reviewed
6Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, acr ai central product, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-02.
- K243209 FDA decision source U.S. Food and Drug Administration · 2026-08-31
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- nordicMEDiVA model card (K243209) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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