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qXR-LN

QURE.AI TECHNOLOGIES PRIVATE LIMITED · Model 1.0.0 · UDI-DI 00850057636024

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Description

The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30 mm in size. The device is intended to be used in the incidental adult population. It is designed to aid the physician to review the frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems as a second reader and be used with any DICOM viewer or PACS . qXR-LN provides adjunctive information only and is not a substitute for the original chest radiographic image

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.