Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K250525.
exact submission · checked 2026-09-04FDA-cleared profile
Second Opinion® Panoramic
Pearl, Inc.
Second Opinion Panoramic is an automated image-processing aid that identifies and marks regions of interest for caries, periapical radiolucency, and impacted third molars on panoramic radiographs of permanent teeth in patients aged 16 years and older.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Second Opinion Panoramic is an automated image-processing aid that identifies and marks regions of interest for caries, periapical radiolucency, and impacted third molars on panoramic radiographs of permanent teeth in patients aged 16 years and older.
- Intended users
- Dental health professionals.
- Care setting and population
- Clinical dental imaging and panoramic-radiograph review workflows.
- Workflow role
- Concurrent second-reader support for labeled panoramic dental findings.
- Required input
- Panoramic radiographs of permanent teeth in patients aged 16 years and older.
- Output and human action
- Marked regions of interest for caries, periapical radiolucency, and impacted third molars.
- Limitations
- The FDA labeling states that the software should not replace a full patient evaluation or be solely relied on for diagnosis. Age, dentition, radiograph, and professional-review limits apply.
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
- The exact FDA package describes automated processing of panoramic radiographs and marked output for dental-professional review; the complete local interface contract remains unknown.
- Deployment and data flow
- On-cloud
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
Public materials reviewed for this exact submission 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
- Use by dental health professionals. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K250525.
Deployment boundary
The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.
exact submission · checked 2026-09-04Interoperability acceptance
The exact FDA package describes automated processing of panoramic radiographs and marked output for dental-professional review; the complete local interface contract remains unknown.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K250525.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- K250525 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for Second Opinion Panoramic. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K250525 FDA evidence package for Second Opinion® Panoramic
FDA 510(k) decision evidence and product verification for the exact submission. · Permanent teeth; caries, periapical radiolucency, and impacted third molars
exact submission · Tested version: Second Opinion Panoramic · Sponsor or vendor studyK250525
FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.
Economics and lifecycle
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
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value 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
- No record matched K250525 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
10Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
The snapshot contained no PubMed or ClinicalTrials.gov candidates; no 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-04.
- FDA 510(k) decision material K250525: Second Opinion® Panoramic U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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