CardiacDevices & AI clearances

FDA Clears Siemens' syngo.CT Coronary Cockpit for Coronary CT Analysis

FDA 510(k) — Radiology devicesJun 25

FDA 510(k) clearance granted to Siemens Healthineers' syngo.CT Coronary Cockpit, a software tool designed to aid interpretation of coronary CT angiography.

  • Manufacturer: Siemens Medical Solutions USA, Inc.
  • Intended to assist in the analysis of coronary CT angiography exams.
  • 510(k) number K253786, product code QIH (radiology image processing system).
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