FDA 510(k)

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family

N.º K: K261315 · 2026-05-21

SolicitanteSiemens Medical Solutions USA, Inc.

Fecha de decisión2026-05-21

Código de productoKPS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family 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 2026-05-21 under 510(k) number K261315. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family?

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K261315.

When did Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family receive FDA 510(k) clearance?

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family received FDA 510(k) clearance on 2026-05-21, under 510(k) number K261315.

Who is the listed applicant for Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family?

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 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family?

The FDA product code for Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family is KPS.

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Otros registros que enlistan a Siemens Medical Solutions USA, Inc. como solicitante

K260055syngo.CT Brain Quantification K261696ACUNAV Luxera 4D ICE Catheter K260488MULTIX Impact; MULTIX Impact C K253786syngo.CT Coronary Cockpit K253678MAMMOMAT B.brilliant (11372950)K260844Sistema de Ultrasonido Diagnóstico ACUSON Sequoia; Sistema de Ultrasonido Diagnóstico ACUSON Sequoia Select; Sistema de Ultrasonido Diagnóstico ACUSON Origin; Sistema de Ultrasonido Diagnóstico ACUSON Origin ICE

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Dispositivos relacionados (Código: KPS)

Fuente oficial

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