syngo.CT Coronary Cockpit— 510(k) K253786
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K253786 for syngo.CT Coronary Cockpit, Substantially Equivalent on 2026-06-25. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's syngo.CT Coronary Cockpit is filed under QIH, automated radiological image processing software. The name points to coronary CT images, but the record doesn't describe the processing it performs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Siemens filed from Knoxville, Tennessee. The decision came 211 calendar days after FDA received it (November 26, 2025 to June 25, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Knoxville, TN, US
Recent devices under product code QIH
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