Radiology AI Directory

FDA-cleared profile

Veuron-Brain-pAb3

Heuron Co., Ltd.

Authorized purpose: Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a stand-alone dementia diagnosis.

Quantification and segmentationNeuro 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: Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a stand-alone dementia diagnosis.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a stand-alone dementia diagnosis.

Evidence takeaway

Evidence from the reviewed source record: Software verification and validation demonstrated the new functions perform as intended; no clinical testing was conducted.

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
Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a stand-alone dementia diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Medical professionals assessing amyloid PET brain imaging.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Care setting and population
Medical-imaging workstations used for PET and MRI brain review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Multimodality registration, fusion, visualization, and quantitative amyloid PET analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Brain amyloid PET and supporting MRI images for the labeled tracer and disease workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
Registered and fused images plus target-to-reference standard uptake value ratios and visualizations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
Calculated results are reference information to support professional assessment and are not a stand-alone diagnosis of dementia.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

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
K231642
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication states that the software processes multiple modalities including MRI and PET; MRI alone is too narrow. Controlled directory display reconciled from exact FDA wording: MRI and PET -> MRI.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-10-13
  • 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 cleared software is deployed through a medical-imaging workplace and organizes processing by radiotracer and disease workflow; local interfaces require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • 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.

Current product-family workflow context

Heuron identifies Veuron-Brain-pAb3 in its product history and separately reports organization-level security certifications; those certifications are not treated as exact-release assurance.

product family ยท checked 2026-09-08

Confirm exact-release availability, interfaces, hosting, security, support, and commercial terms during procurement.

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
Software verification and validation demonstrated the new functions perform as intended; no clinical testing was conducted.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact 510(k) summary states the testing boundary and explicitly reports no clinical testing.

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.

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 K231642 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 K231642. 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
21Fields reviewed
10Source 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, vendor company page, fda device recall, literature index, trial registry, fda decision summary packet, 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 K231642: Veuron-Brain-pAb3

    U.S. Food and Drug Administration - Published 2023-10-13 - Accessed 2026-09-19

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  6. openFDA exact recall query for K231642

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

    Scope: postmarketSafety

  7. Heuron company and product history

    Heuron - Accessed 2026-09-08

    Scope: productFamily, regulatoryHistory, vendorWideSecurity

Research history

  1. K231642 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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