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
VUNO Med-DeepBrain
VUNO Inc.
Authorized purpose: Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
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: Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain, including segmentable cortical/subcortical structures, vessels, and WMH/lesion regions. Input: 3D T1-weighted brain MR images and 2D T2 FLAIR brain MR images; the comparison table specifies 1.5T and 3T input.
- Who uses it? Intended users: Trained healthcare professionals who work with medical imaging.
- What does the software produce? Output: 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.
- What is its most important limitation? Key limitation: 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.
Clinical takeaway
Clinical role: Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
Evidence takeaway
Evidence from the reviewed source record: 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.
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.
- Intended users
- Trained healthcare professionals who work with medical imaging.
- Care setting and population
- Office-like environment; the packet also describes cloud-based deployment and does not establish a more specific facility type.
- Workflow role
- Segmentation, labeling, volumetric quantification, and report visualization.
- Required input
- 3D T1-weighted brain MR images and 2D T2 FLAIR brain MR images; the comparison table specifies 1.5T and 3T input.
- 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.
- 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.
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.
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.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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.
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 2026-09-08Evidence
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.
- 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.
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.
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
No public price or quote for the exact K231398 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K231398 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 1 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
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FDA K231398: VUNO Med-DeepBrain
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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VUNO Med-DeepBrain model card (K231398)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K231398
Scope: postmarketSafety
Research history
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K231398 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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