FDA 510(k)

syngo.CT Coronary Cockpit

Número K: K253786 · 2026-06-25

RequerenteSiemens Medical Solutions USA, Inc.

Data da decisão2026-06-25

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

syngo.CT Coronary Cockpit is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253786. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the syngo.CT Coronary Cockpit?

syngo.CT Coronary Cockpit is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K253786.

When did syngo.CT Coronary Cockpit receive FDA 510(k) clearance?

syngo.CT Coronary Cockpit received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253786.

Who is the listed applicant for syngo.CT Coronary Cockpit?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.CT Coronary Cockpit?

The FDA product code for syngo.CT Coronary Cockpit is QIH.

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Fonte oficial

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