Radiology AI Directory

FDA-cleared profile

Second Opinion® CS

Pearl Inc.

Authorized purpose: Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and percentage analysis in context.

Detection and CADeQuantification 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.

Product overview

Start with the essentials

Authorized purpose: Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and percentage analysis in context.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and percentage analysis in context.

Evidence takeaway

Evidence from the reviewed source record: Study type: Both. Cases: 1250. Reported sensitivity: 88%. Reader-study cases: 330. Readers: 21

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
Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and percentage analysis in context.
  • 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 health professionals (dentists)
  • 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: Periapical radiographs of permanent teeth in patients 12 years of age or 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 a visual overlay of segmented contours highlighting detected carious lesions on the periapical radiograph. It provides detection of caries and a detailed analysis of the lesion's overlap with dentin and enamel, presented as a percentage. The clinician can hover over detected caries to view a segmentation analysis in the form of percentages.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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

Limitations
The system is a second reader and does not replace complete dentist review or clinical judgment; family marketing and help content do not establish exact K243234 release behavior.
  • 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
K243234
  • 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
2025-06-12
  • 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 imaging workflow

The official Second Opinion page says the family product integrates directly with the imaging system and analyzes bitewing, periapical, and panoramic images automatically.

product family · checked 2026-09-06

Exact K243234 connector versions and current commercial terms 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: Both. Cases: 1250. Reported sensitivity: 88%. Reader-study cases: 330. Readers: 21
  • 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%
  • 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
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.

Second Opinion® CS 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 K243234
  • Samplen=1250
  • IndependenceIndependence not established

K243234

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
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

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
26Fields 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. K243234 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. Second Opinion® CS model card (K243234)

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

    Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, 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 K243234: Second Opinion CS

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

    Scope: identity, clinical, evidence, implementation

  8. Second Opinion AI

    Pearl - Accessed 2026-09-06

    Scope: buyer_workflow, clinical, implementation

  9. What does Second Opinion detect?

    Pearl - Accessed 2026-09-06

    Scope: clinical, limitations, implementation

Research history

  1. K243234 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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