CXRDetectAI Receives FDA 510(k) Clearance, K253751

Key Highlights

• FDA 510(k) clearance number K253751 for CXRDetectAI, cleared July 8, 2026
• Cleared as Radiological Computer Aided Triage and Notification Software (21 CFR 892.2080, Class II, product code QFM)
• Detects chest X-ray abnormalities, including pneumonia, nodules, and pulmonary effusion, with 94% sensitivity versus 65% manual detection
• Identifies tuberculosis with 90% sensitivity and specificity, reducing missed findings by 83%
• Deploys inside RadioViewAI as an AI-Findings feature, or standalone at facilities that keep their own PACS through the ConnectAI gateway

CXRDetectAI is the third FDA 510(k) cleared module in the SaveLife.AI AI Suite, alongside NeuroICH (K241719) for intracranial hemorrhage detection and MammoSightAI (K252954) for early breast cancer detection. Each clearance applies only to its own module. The CXRDetectAI clearance letter is published on the AI Suite page.