Radiology AI Directory

FDA-cleared profile

Velmeni for Dentists (V4D)

Velmeni Inc.

Authorized purpose: VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. It provides additional information for dentists and is not a replacement for complete examination or clinical judgment; final diagnoses and treatment plans are the dentist's responsibility.

Detection and CADe
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: VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. It provides additional information for dentists and is not a replacement for complete examination or clinical judgment; final diagnoses and treatment plans are the dentist's responsibility.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. It provides additional information for dentists and is not a replacement for complete examination or clinical judgment; final diagnoses and treatment plans are the dentist's responsibility.

Evidence takeaway

Evidence from the reviewed source record: K240003 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.

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
VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. It provides additional information for dentists and is not a replacement for complete examination or clinical judgment; final diagnoses and treatment plans are the dentist's responsibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiologists, dentists, orthopedic clinicians, and other trained radiographic professionals within the labeled use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiographic, orthopedic, dental, or clinical image-review settings within the labeled scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Radiographic image acquisition support, image processing, measurement, planning, or concurrent review under professional control.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported X-ray, radiographic, EOS, dental, or other labeled image inputs and associated study data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Processed radiographs, measurements, landmarks, annotations, planning views, and review information for professional use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The FDA table reports subgroup reader-study endpoints for the exact V4D submission; do not generalize them beyond the labeled dental radiograph types, permanent-tooth population, conditions, study design, or tested version.
  • 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
K240003
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Permanent teeth; digital bitewing, periapical, and panoramic dental radiographs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-08-30
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

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
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 radiologists, dentists, orthopedic clinicians, and other trained radiographic professionals within the labeled use should operate or interpret the product. Local onboarding should 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 K240003 by exact hardware, software, model, and 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: The FDA table reports subgroup reader-study endpoints for the exact V4D submission; do not generalize them beyond the labeled dental radiograph types, permanent-tooth population, conditions, study design, or tested version.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is 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 K240003 before acceptance.

exact submission · checked 2026-09-04

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

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

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. The FDA table reports subgroup reader-study endpoints for the exact V4D submission; do not generalize them beyond the labeled dental radiograph types, permanent-tooth population, conditions, study design, or tested version.

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.

exact submission · checked 2026-09-04

No exact-product price or reimbursement determination was promoted.

Source

Lifecycle monitoring

Monitor K240003 by exact hardware, software, model, and 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: The FDA table reports subgroup reader-study endpoints for the exact V4D submission; do not generalize them beyond the labeled dental radiograph types, permanent-tooth population, conditions, study design, or tested version.

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
K240003 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
95%; 74.6%; 69.5%; 0.3%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Reported specificity
95%; 22.5%; 10.6%; 42.9%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Fixed-prosthesis lesion-level sensitivity

88.8 percent

  • EndpointLesion-level sensitivity in the FDA comparison table
  • PopulationFDA reader-study subgroup for fixed prostheses on labeled dental radiographs
  • Tested versionVelmeni for Dentists (V4D) configuration described in K240003
Source

Fixed-prosthesis case-level specificity

97.6 percent

  • EndpointCase-level specificity in the FDA comparison table
  • PopulationFDA reader-study subgroup for fixed prostheses on labeled dental radiographs
  • Tested versionVelmeni for Dentists (V4D) configuration described in K240003
Source

Implant lesion-level sensitivity

88.3 percent

  • EndpointLesion-level sensitivity in the FDA comparison table
  • PopulationFDA reader-study subgroup for implants on labeled dental radiographs
  • Tested versionVelmeni for Dentists (V4D) configuration described in K240003
Source

Restoration lesion-level sensitivity

73 percent

  • EndpointLesion-level sensitivity in the FDA comparison table
  • PopulationFDA reader-study subgroup for restorations on labeled dental radiographs
  • Tested versionVelmeni for Dentists (V4D) configuration described in K240003
Source

Restoration case-level specificity

85.8 percent

  • EndpointCase-level specificity in the FDA comparison table
  • PopulationFDA reader-study subgroup for restorations on labeled dental radiographs
  • Tested versionVelmeni for Dentists (V4D) configuration described in K240003
Source

K240003 FDA decision evidence package for Velmeni for Dentists (V4D)

  • DesignFDA decision evidence including the exact submission's labeled performance or verification material; endpoints remain submission-specific.
  • PopulationPermanent teeth; digital bitewing, periapical, and panoramic dental radiographs
  • Scopeexact submission
  • Tested versionVelmeni for Dentists (V4D) configuration described in K240003
  • IndependenceSponsor or vendor study

K240003

FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; local technical, clinical, privacy, security, and workflow acceptance remains necessary.

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 or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

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

No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.

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 K240003 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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields 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, acr ai central product, fda decision material, 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 510(k) decision material K240003: Velmeni for Dentists (V4D)

    U.S. Food and Drug Administration - Published 2024-08-30 - Accessed 2026-09-04

    Scope: identity, 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. Velmeni for Dentists (V4D) model card (K240003)

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

  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

Research history

  1. K240003 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

Alternatives

Related tools to compare

FDA-cleared K252953

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth...

Modality
X-ray/Radiography
Anatomy
Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
Decision
2026-05-11
MSK and boneDetection and CADe
FDA-cleared K253502

Critical Care Suite with Enteric Tube Positioning AI Algorithm

Ge Medical Systems, LLC

Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways...

Modality
X-ray/Radiography
Anatomy
Chest/lung and abdomen/stomach; enteric tube, tube tip and side port, diaphragm, and airways including carina and left/right bronchi
Decision
2026-04-14
Detection and CADe
FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...

Modality
X-ray/Radiography
Anatomy
Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
Decision
2026-01-16
Cardiac imagingMSK and boneDetection and CADe
FDA-cleared K250264

SugarBug (1.x)

Bench7, Inc.

Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-11-07
Detection and CADeQuantification and segmentation