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Logicon Caries Detector

G. A Industries · Model 4.0 · UDI-DI 00868430000003

510(k) clearances

Adverse events

Recalls

Facilities

Description

Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability.

Recalls

Date	Firm	Reason
2015-04-06	GA Industries	GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
2006-05-04	Riverain Medical Group	The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0
2006-05-04	Riverain Medical Group	The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.