Radiology AI Directory

FDA-cleared profile

VBrain

Vysioneer Inc.

Authorized purpose: VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas and organs at risk from axial T1 contrast-enhanced brain MRI; contours must be finalized on an external DICOM-RT platform.

Neuro MRI
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: VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas and organs at risk from axial T1 contrast-enhanced brain MRI; contours must be finalized on an external DICOM-RT platform.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas and organs at risk from axial T1 contrast-enhanced brain MRI; contours must be finalized on an external DICOM-RT platform.

Evidence takeaway

Evidence from the reviewed source record: The K213628 FDA decision material describes regression verification and validation for the modified VBrain device with all listed tests passed; it does not provide a numeric clinical performance endpoint or establish autonomous contour approval.

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
VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas and organs at risk from axial T1 contrast-enhanced brain MRI; contours must be finalized on an external DICOM-RT platform.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiation oncologists, radiation planners, dosimetrists, and other trained professionals involved in brain radiation-treatment planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiation oncology planning workflows using brain MRI, PACS, and an external DICOM-RT treatment-planning platform.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Retrieves brain MR images, applies tumor and organ-at-risk contouring and registration algorithms, and returns editable DICOM-RT structures for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Adult axial T1 contrast-enhanced brain MRI from PACS, with known or diagnosed tumors in the labeled categories and supported MR/CT registration data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Initial tumor and organ-at-risk contours and rigidly registered MR/CT structures in DICOM-RT RTSTRUCT format.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Adults and known or diagnosed brain metastases, meningiomas, or acoustic neuromas only; other tumor types and body parts are outside the labeled scope, the system is not for diagnosis, and every contour must be reviewed, modified, and confirmed on the external treatment-planning platform.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K213628
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-12-16
  • 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
The FDA material describes PACS retrieval and return of DICOM data, rigid MR/CT registration, and export of editable DICOM-RT RTSTRUCT to an external treatment-planning platform.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.

Deployment and data flow
The FDA material describes a PACS-connected radiation-planning workflow with an external DICOM-RT platform; current server placement, hosting, security, retention, availability, and site configuration remain unverified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the release-level boundary described in the exact FDA decision material; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only Radiation oncologists, radiation planners, dosimetrists, and other trained professionals involved in brain radiation-treatment planning should operate or interpret the product; local onboarding must cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K213628 by exact hardware, software, model, algorithm version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: Adults and known or diagnosed brain metastases, meningiomas, or acoustic neuromas only; other tumor types and body parts are outside the labeled scope, the system is not for diagnosis, and every contour must be reviewed, modified, and confirmed on the external treatment-planning platform.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K213628 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Deployment boundary

The FDA material describes a PACS-connected radiation-planning workflow with an external DICOM-RT platform; current server placement, hosting, security, retention, availability, and site configuration remain unverified.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The FDA material describes PACS retrieval and return of DICOM data, rigid MR/CT registration, and export of editable DICOM-RT RTSTRUCT to an external treatment-planning platform.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Adults and known or diagnosed brain metastases, meningiomas, or acoustic neuromas only; other tumor types and body parts are outside the labeled scope, the system is not for diagnosis, and every contour must be reviewed, modified, and confirmed on the external treatment-planning platform.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K213628 by exact hardware, software, model, algorithm version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

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
The K213628 FDA decision material describes regression verification and validation for the modified VBrain device with all listed tests passed; it does not provide a numeric clinical performance endpoint or establish autonomous contour approval.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K213628 FDA evidence package for VBrain

  • DesignFDA 510(k) software regression verification and validation for tumor, organ-at-risk, registration, and DICOM-RT functions.
  • PopulationSupported adult brain MRI and DICOM-RT treatment-planning workflows for the labeled tumor categories.
  • Scopeexact submission
  • Tested versionVBrain configuration described in K213628
  • IndependenceSponsor or vendor study

K213628

All listed tests passed in the FDA summary; manual finalization and external-platform review remain required.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K213628 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

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.

Human reviewedStatus
2026-09-04Last searched
32Fields reviewed
11Source classes checked
7Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Screened seven PubMed records. PMID 37016416 identifies VBrain by Vysioneer but does not identify the tested software version or K213628; the other six are alias collisions. All seven were quarantined and none was promoted. The current discovery snapshot contains 7 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 decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) decision material K213628: VBrain

    U.S. Food and Drug Administration - Published 2021-12-16 - Accessed 2026-09-04

    Scope: identity, productIdentity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Vbrain model card (K213628)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, integration, anatomy, 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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K213628 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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