FDA AI Clearance Tracker/K253786

Radiology · 510(k)

syngo.CT Coronary Cockpit

Siemens Medical Solutions USA, Inc.

Device
syngo.CT Coronary Cockpit
Company
Siemens Medical Solutions USA, Inc.
Submission number
K253786
Pathway
510(k)
Decision date
Jun 25, 2026
Specialty (lead panel)
Radiology
Primary product code
QIH

Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.