LOGICON CARIES DETECTOR

Evidence summary

The FDA PMA record supports the adjunct caries-detection indication. The FDA recall database identifies terminated recall Z-1537-2015 for version 5.0 released without prior FDA approval; confirm installed version and correction status.

FDA source Exact FDA submission Checked 2026-09-03

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

Postmarket safety review

FDA recall Z-1537-2015 concerned LOGICON Caries Detector version 5.0 released without prior FDA approval; FDA lists the recall as terminated. Confirm the installed version and regulatory history.

Public source Exact FDA submission Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

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1 native-identifier FDA recall candidate awaits human confirmation of the exact product, version, and affected configuration before publication.

• Verify security and privacy controls: Public materials reviewed for this exact release 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 for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA materials, available current product-family sources, reimbursement context, and exact-identifier postmarket results were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 6 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 1 postmarket candidate record; 0 have been reviewed (0 published, 0 rejected) and 1 remains unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, acr ai central product, fda decision material, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• P980025 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Logicon Caries Detection Software model card (P980025) American College of Radiology · 2026-09-01
• 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
• FDA recall Z-1537-2015 for LOGICON Caries Detector U.S. Food and Drug Administration · 2026-09-03