Radiology AI Directory

FDA-cleared profile

VUNO Med-DeepBrain

VUNO Inc.

Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.

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

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
Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained healthcare professionals who work with medical imaging.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Office-like environment; the packet also describes cloud-based deployment and does not establish a more specific facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Segmentation, labeling, volumetric quantification, and report visualization.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
3D T1-weighted brain MR images and 2D T2 FLAIR brain MR images; the comparison table specifies 1.5T and 3T input.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic segmentation/labeling of 104 brain structures including two vessels, WMH and lesion quantification from T2 FLAIR, volumetric measurements, color-map visualization, normative-percentile/prior comparison when applicable, and downloadable/printable reports.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Results should be reviewed by a trained physician; the packet describes quality-control checks, outlier removal, and user review of inappropriate/hidden regions. No clinical test was required for substantial equivalence, so the packet does not establish diagnostic outcome performance.
  • 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
K231398
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain, including segmentable cortical/subcortical structures, vessels, and WMH/lesion regions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-10-04
  • 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
Data can be received from and sent to PACS using DICOM; the comparison table describes a cloud-based software package installed on user hardware.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • 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 VUNO Med-DeepBrain; 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 K231398 reports nonclinical verification/validation plus segmentation-accuracy and test-retest reproducibility testing; no clinical test was required. Segmentation used Dice Similarity Coefficient with acceptance criteria of 0.80 for brain and WMH regions, and reproducibility used ICC criteria of 0.965 for brain structures and 0.988 for WMH; reported results exceeded criteria. The packet gives no test-set sample size.
  • 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.

VUNO Med-DeepBrain regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231398
  • IndependenceIndependence not established

K231398

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 K231398 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 K231398. 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
2026-09-08Last searched
22Fields reviewed
9Source classes checked
1Awaiting review PubMed leads
0Awaiting review 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. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 1 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, 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 K231398: VUNO Med-DeepBrain

    U.S. Food and Drug Administration - Published 2023-10-04 - 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. VUNO Med-DeepBrain model card (K231398)

    American College of Radiology - Published 2026-09-01 - 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 K231398

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

    Scope: postmarketSafety

Research history

  1. K231398 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K261405

ANDI 2.2

Imeka Solutions, Inc.

ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...

Modality
MRI
Anatomy
Brain
Decision
2026-05-28
Quantification and segmentationNeuro MRI
FDA-cleared K261273

Neurophet AQUA

Neurophet., Inc.

Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric...

Modality
MRI
Anatomy
Brain; segmentable structures and lesions
Decision
2026-05-15
Quantification and segmentation
FDA-cleared K260032

Morph

BeauBrain Healthcare, Inc.

Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...

Modality
MRI
Anatomy
Brain
Decision
2026-05-13
Quantification and segmentationNeuro MRI
FDA-cleared K254015

CoLumbo C-Spine

Smart Soft Healthcare AD

Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for...

Modality
MRI
Anatomy
Cervical spine: vertebrae C3-C7 and disks C2C3 through C7T1
Decision
2026-04-01
MSK and boneQuantification and segmentation