ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Videa Dental Assist; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08FDA-cleared profile
Videa Dental Assist
VideaHealth, Inc.
Authorized purpose: Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and older, with indication-specific age and view limits; suspect dental-finding indications are adjunctive and diagnostic use is limited to dentists.
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: Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and older, with indication-specific age and view limits; suspect dental-finding indications are adjunctive and diagnostic use is limited to dentists.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and older, with indication-specific age and view limits; suspect dental-finding indications are adjunctive and diagnostic use is limited to dentists.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Dental/Maxillofacial (suspected findings, historical treatments, and normal anatomy) Input: Eligible bitewing, periapical, or panoramic intraoral radiographs from patients aged 3 years and older with primary, mixed, and/or permanent dentition, subject to indication-specific limits: some findings require age 12 or 22 and permanent dentition, and panoramic use is for historical-treatment and normal-anatomy indications.
- Who uses it? Intended users: Trained dental professionals including dentists and dental hygienists; only dentists performing diagnostic activities should use suspect dental-finding indications.
- What does the software produce? Output: For each indication, a binary present/absent result; when findings are present, the number by finding type and bounding-box coordinates, and when absent, a clear no-findings indication. Results cover all findings on one radiograph regardless of tooth count.
- What is its most important limitation? Key limitation: Not a substitute for full patient evaluation or sole basis to make or confirm a diagnosis. Indication-specific gates apply: caries and many findings are tested on bitewing/periapical images from age 3, pulp stones require age 12 and permanent dentition, periapical radiolucency and furcation require age 22 and permanent dentition, and panoramic images are limited to the historical-treatment and normal-anatomy scopes. Historical-treatment and normal-anatomy outputs are not diagnostic aids. The FDA standalone study reports that caries specificity was the only suspect-finding specificity not to meet its standalone target, although the indication passed the clinical-study criteria.
Clinical takeaway
Clinical role: Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and older, with indication-specific age and view limits; suspect dental-finding indications are adjunctive and diagnostic use is limited to dentists.
Evidence takeaway
Evidence from the reviewed source record: FDA K232384 reports standalone testing on 1,445 radiographs from more than 35 US sites, ground-truthed by three US board-certified dentists across 17 sensor manufacturers, with all listed indications in scope. All historical-treatment and normal-anatomy indications met sensitivity/specificity criteria; all suspect dental findings met criteria except caries specificity, which still passed the clinical-study criteria. A separate clinical reader study used 378 radiographs from more than 25 US locations, 26 readers, and dentist labeling/adjudication; AFROC reader improvements included 4.3% for caries, 28.5% for attrition, and 11.5% for periapical radiolucency.
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
- Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and older, with indication-specific age and view limits; suspect dental-finding indications are adjunctive and diagnostic use is limited to dentists.
- Intended users
- Trained dental professionals including dentists and dental hygienists; only dentists performing diagnostic activities should use suspect dental-finding indications.
- Care setting and population
- Dental-practice workflow; FDA testing covered more than 35 US sites, but the indication does not specify a facility type.
- Workflow role
- Adjunct detection and localization for dental image review and practice operations, with indication-specific outputs for diagnostic suspect findings, historical treatments, and normal anatomy.
- Required input
- Eligible bitewing, periapical, or panoramic intraoral radiographs from patients aged 3 years and older with primary, mixed, and/or permanent dentition, subject to indication-specific limits: some findings require age 12 or 22 and permanent dentition, and panoramic use is for historical-treatment and normal-anatomy indications.
- Output and human action
- For each indication, a binary present/absent result; when findings are present, the number by finding type and bounding-box coordinates, and when absent, a clear no-findings indication. Results cover all findings on one radiograph regardless of tooth count.
- Limitations
- Not a substitute for full patient evaluation or sole basis to make or confirm a diagnosis. Indication-specific gates apply: caries and many findings are tested on bitewing/periapical images from age 3, pulp stones require age 12 and permanent dentition, periapical radiolucency and furcation require age 22 and permanent dentition, and panoramic images are limited to the historical-treatment and normal-anatomy scopes. Historical-treatment and normal-anatomy outputs are not diagnostic aids. The FDA standalone study reports that caries specificity was the only suspect-finding specificity not to meet its standalone target, although the indication passed the clinical-study criteria.
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
- Cloud-based Videa Dental Assist is accessed through an API behind a firewalled network and a dental image viewer; authenticated users upload eligible images and review returned bounding boxes and finding statuses. The FDA packet does not establish DICOM, PACS, RIS, EHR, or a specific production deployment.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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.
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 K232384 reports standalone testing on 1,445 radiographs from more than 35 US sites, ground-truthed by three US board-certified dentists across 17 sensor manufacturers, with all listed indications in scope. All historical-treatment and normal-anatomy indications met sensitivity/specificity criteria; all suspect dental findings met criteria except caries specificity, which still passed the clinical-study criteria. A separate clinical reader study used 378 radiographs from more than 25 US locations, 26 readers, and dentist labeling/adjudication; AFROC reader improvements included 4.3% for caries, 28.5% for attrition, and 11.5% for periapical radiolucency.
- 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.
Videa Dental Assist regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult and Pediatric
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K232384
- Samplen=1445
- Sites35
- IndependenceIndependence not established
K232384
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 K232384 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 K232384. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 K232384 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
21Fields reviewed
9Source 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 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 K232384: Videa Dental Assist
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Videa Dental Assist model card (K232384)
Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
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PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K232384
Scope: postmarketSafety
Research history
-
K232384 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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