Siemens Healthineers AG

3 AI-enabled medical devices from Siemens Healthineers AG on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-06-15K253690LungMapsSiemens Healthineers AGRadiology
2026-01-15K253023BIOGRAPH OneSiemens Healthineers AGRadiology
2025-10-24K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AGRadiology

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