Authorized purpose: Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical treatments, and normal anatomy; diagnostic use remains with trained dental 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: Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical treatments, and normal anatomy; diagnostic use remains with trained dental professionals.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical treatments, and normal anatomy; diagnostic use remains with trained dental professionals.
Which images or clinical context are in scope?Modality: X-ray/Radiography Anatomy or clinical context: Dental/Maxillofacial Input: XRAY images or data. Inclusion criteria: Bitewing, periapical, and panoramic intraoral radiographs acquired from patients aged 3 years or older with primary, mixed, and/or permanent dentition undergoing routine dental visits or suspected of one of the suspected dental findings listed in the indications for use.
Who uses it?Intended users: Trained dental professionals including dentists and dental hygienists. Only dentists performing diagnostic activities shall use the suspect dental finding indications.
What does the software produce?Output: The device outputs a binary indication to identify the presence or absence of findings for each indication. If findings are present, the device outputs the number of findings by finding type and the coordinates of bounding boxes and/or segmentation outlines for each finding. If no findings are present, the device outputs a clear indication that there are no findings identified for each indication. For caries and calculus, a segmentation (isocontour) view is available as an alternative to bounding boxes. For caries and periapical radiolucency, a second operating point (high sensitivity vs. high specificity) is available as a user toggle. Normal tooth anatomy segmentations (enamel, pulp, crown dentin, root dentin) can be toggled on and off.
What is its most important limitation?Key limitation: The outputs are suspected findings and normal-anatomy or historical-treatment annotations for clinician review; the FDA indication does not make the software a stand-alone diagnosis or treatment planner.
Clinical takeaway
Clinical role: Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical treatments, and normal anatomy; diagnostic use remains with trained dental professionals.
Evidence takeaway
Evidence from the reviewed source record: Study type: Both. Cases: 1445. Sites: 35. Reader-study cases: 378. Readers: 20
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
Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical treatments, and normal anatomy; diagnostic use remains with trained dental professionals.
FDA source
Exact FDA submission
Checked 2026-09-06
Exact clinical-use normalization from the FDA packet; this text is also the locked corrections value.
Trained dental professionals including dentists and dental hygienists. Only dentists performing diagnostic activities shall use the suspect dental finding indications.
Public source
Exact FDA submission
Checked 2026-09-01
Intended-user text reported in the exact-submission ACR model card.
XRAY images or data. Inclusion criteria: Bitewing, periapical, and panoramic intraoral radiographs acquired from patients aged 3 years or older with primary, mixed, and/or permanent dentition undergoing routine dental visits or suspected of one of the suspected dental findings listed in the indications for use.
Public source
Exact FDA submission
Checked 2026-09-01
Conservative normalization of explicit wording in an exact-submission source.
The device outputs a binary indication to identify the presence or absence of findings for each indication. If findings are present, the device outputs the number of findings by finding type and the coordinates of bounding boxes and/or segmentation outlines for each finding. If no findings are present, the device outputs a clear indication that there are no findings identified for each indication. For caries and calculus, a segmentation (isocontour) view is available as an alternative to bounding boxes. For caries and periapical radiolucency, a second operating point (high sensitivity vs. high specificity) is available as a user toggle. Normal tooth anatomy segmentations (enamel, pulp, crown dentin, root dentin) can be toggled on and off.
Public source
Exact FDA submission
Checked 2026-09-01
Clinical output reported in the exact-submission ACR model card.
The outputs are suspected findings and normal-anatomy or historical-treatment annotations for clinician review; the FDA indication does not make the software a stand-alone diagnosis or treatment planner.
FDA source
Exact FDA submission
Checked 2026-09-06
Exact-product limitations and clinician-review boundary from the FDA packet.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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 category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Family imaging-software compatibility list
The official FAQ lists multiple supported dental imaging environments, including Carestream, DEXIS, SOTA, Sidexis, MiPACS, ClearDent, Tracker, CADI, and Patterson Imaging.
product family ยท checked 2026-09-06
Exact K251002 release, interface versions, and local compatibility require confirmation.
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.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Videa Dental AI 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 K251002
Samplen=1445
Sites35
IndependenceIndependence not established
K251002
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 2026-09-06
Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-08-31
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
25Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored exact-submission candidate metadata had zero PubMed and ClinicalTrials.gov identifiers; this metadata screening is not a full paper or registry-record review. 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, vendor product page, 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 history8 sources - 3 history items
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