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RevealAI-Lung

Precision Medical Ventures Inc. · Model v1.x · UDI-DI 00860012425303

POK Prescription
1
510(k) clearances
1
Adverse events
0
Recalls
16
Facilities

Description

RevealAI-Lung Software is a computer aided diagnostic (CADx) software application intended for the characterization of incidentally-detected lung nodules on computed tomography (CT) scans. When a nodule is identified, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians’ assessment of patients’ cancer risk.

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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.