FDA cleared the syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on Jun 25, 2026 under K253786, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.
FDA logged the submission as received on Nov 26, 2025. The decision came 211 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K253678 (MAMMOMAT B.brilliant (11372950)), K260844 (ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System), K261315 (Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family), K254184 (syngo Application Software).