Radiology AI Directory

FDA-cleared profile

DTX Studio Assist

Nobel Biocare C/O Medicim NV

Analyzes two-dimensional bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at an existing restoration margin, and bone loss; also supports alveolar bone-level measurement and restoration/dental-anatomy segmentation as an adjunct to dentist review.

MSK and boneQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

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 two-dimensional bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at an existing restoration margin, and bone loss; also supports alveolar bone-level measurement and restoration/dental-anatomy segmentation as an adjunct to dentist review.
  • 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.

Intended users
Dental professionals
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult and Pediatric
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Segmentation or contouring
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Conservative normalization of explicit wording in an exact-submission source.

Required input
XRAY images or data. Inclusion criteria: Two-dimensional bitewing and periapical intraoral radiographs (IORs) of permanent teeth in patients aged 15 and older
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
The AI model outputs detection and localization of dental findings including caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration, and bone loss via bounding boxes and segmentation masks. It also outputs alveolar bone level measurements (mesial and distal), detection and segmentation of dental restorations (amalgam fillings, composite fillings, prosthetic crowns, bridges, implants, implant abutments, root canal fillings and posts), and segmentation of dental anatomy structures (enamel, dentine, pulp, bone, and artificial structures).
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
The SDK is an adjunct to complete dentist review and clinical judgment; the packet describes a documented API bundled into host software and does not establish the current host application's release, commercial terms, or local compatibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Exact-product limitations and clinician-review boundary from the FDA packet.

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
K252086
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Imaging modality reported in the exact-submission ACR AI Central model card.

Anatomy
Dental/Maxillofacial
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Anatomy normalized from explicit exact-submission ACR model-card wording.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-11-17
  • 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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

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 image and collaboration workflow

The DTX Studio Clinic family page describes centralized access to patient images, diagnostics and treatment planning, with sharing to labs and treatment partners.

product family · checked 2026-09-06

Family page; current host configuration and K252086 SDK interfaces require confirmation.

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
Study type: Stand-Alone Performance. Cases: 1530. Reported sensitivity: 88.8%. Reported specificity: 96.6%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

Reported sensitivity
88.8%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
96.6%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

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

DTX Studio Assist regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult and Pediatric
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K252086
  • Samplen=1530
  • IndependenceIndependence not established

K252086

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

No current DTX price is established. The previously identified DEXIS URL returned 404 on final check and no cached dated page content is retained; the source is not registered or cited.

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

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
2026-09-07Last searched
27Fields 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 history

Source ledger

  1. K252086 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. DTX Studio Assist model card (K252086)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  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

  7. FDA 510(k) decision material K252086: DTX Studio Assist

    U.S. Food and Drug Administration - Accessed 2026-09-06

    Scope: identity, clinical, evidence, implementation

  8. DTX Studio Clinic product page

    Nobel Biocare - Accessed 2026-09-06

    Scope: buyer_workflow, implementation, integration

Research history

  1. K252086 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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