Radiology AI Directory

FDA-cleared profile

nordicMEDiVA

NordicNeurolab AS

Authorized purpose: Analyze and visualize functional and dynamic brain MR data and present derived properties and parameters in a clinically useful context for qualified medical personnel; it is not a sole basis for clinical decisions or emergency care.

MRI workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Analyze and visualize functional and dynamic brain MR data and present derived properties and parameters in a clinically useful context for qualified medical personnel; it is not a sole basis for clinical decisions or emergency care.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Analyze and visualize functional and dynamic brain MR data and present derived properties and parameters in a clinically useful context for qualified medical personnel; it is not a sole basis for clinical decisions or emergency care.

Evidence takeaway

Evidence from the reviewed source record: FDA K243209 reports non-clinical verification and validation, usability studies, and comparisons of diffusion/tractography and BOLD results with predicate/reference outputs reviewed by internal and external clinical experts. DSC results were compared with reference device K241608 using Lin's concordance correlation coefficient with an acceptance criterion >= 0.8; the packet does not state the achieved CCC value. No numeric sensitivity, specificity, AUC, or disease-detection performance endpoint is reported.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Analyze and visualize functional and dynamic brain MR data and present derived properties and parameters in a clinically useful context for qualified medical personnel; it is not a sole basis for clinical decisions or emergency care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Qualified medical personnel, including trained radiological technicians and physicians with training in MR technology and neuroanatomy.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Clinical brain-MRI post-processing and visualization; the FDA packet states no patient-population limitation but excludes use as the sole basis in emergency care applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing analysis and visualization of functional/dynamic brain MRI with review and export to downstream imaging or navigation systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM functional and dynamic brain MRI from DICOM-compliant devices and modalities, including BOLD task-based fMRI, diffusion MRI, and DSC-perfusion MRI data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
BOLD voxel-wise task-activation statistics, DTI/SD-derived FA and MD maps, 3D tractography of major white-matter pathways, DSC perfusion maps for blood volume, blood flow, time to peak, mean transit time, and leakage, with browser review and export to DICOM nodes, PACS, neuro-navigation systems, or other DICOM-compliant modalities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not an archive for long-term persistent storage of diagnostic data; not a sole basis for clinical decisions or emergency-care applications; limited to analysis and visualization of human-brain MR data or data derived from it. Qualified users with MR and neuroanatomy training are required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-10-22
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Server-client solution accessed through a browser, with DICOM functionality, APIs, configurable pipelines, and connections to MR modalities, PACS, and surgical-navigation systems. The packet permits local customer-server deployment or cloud/SaaS deployment using a containerized GPU-enabled Linux host; exact interfaces and hosting configuration require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Hybrid
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for nordicMEDiVA; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA K243209 reports non-clinical verification and validation, usability studies, and comparisons of diffusion/tractography and BOLD results with predicate/reference outputs reviewed by internal and external clinical experts. DSC results were compared with reference device K241608 using Lin's concordance correlation coefficient with an acceptance criterion >= 0.8; the packet does not state the achieved CCC value. No numeric sensitivity, specificity, AUC, or disease-detection performance endpoint is reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

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

  • DesignStand-Alone Performance
  • PopulationAdult and Pediatric
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K243209
  • IndependenceIndependence not established

K243209

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K243209 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K243209. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K243209: nordicMEDiVA

    U.S. Food and Drug Administration - Published 2024-10-22 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. nordicMEDiVA model card (K243209)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K243209

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K243209 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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