Siemens Gets FDA Clearance for LungMaps AI-Powered Chest Radiography Software

Siemens Healthineers received FDA 510(k) clearance for LungMaps, a software device that uses AI to analyze chest X-rays. It aims to support clinicians by highlighting potential findings and generating a preliminary report. Specific performance metrics, such as sensitivity and sp…

• Clearance is for the LungMaps software device (product code QIH), manufactured by Siemens Healthineers AG.
• The software is intended to assist in the interpretation of chest radiographs through AI-based image analysis.
• No predicate device or detailed performance data (e.g., AUC, sensitivity) were provided in the source abstract.

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