FDA 510(k)

syngo.CT Single Source Dual Energy (Twin Beam)

N.º K: K153220 · 2016-02-19

SolicitanteSiemens Medical Solutions USA, Inc.

Fecha de decisión2016-02-19

Código de productoJAK

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

syngo.CT Single Source Dual Energy (Twin Beam) 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 2016-02-19 under 510(k) number K153220. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the syngo.CT Single Source Dual Energy (Twin Beam)?

syngo.CT Single Source Dual Energy (Twin Beam) is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K153220.

When did syngo.CT Single Source Dual Energy (Twin Beam) receive FDA 510(k) clearance?

syngo.CT Single Source Dual Energy (Twin Beam) received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153220.

Who is the listed applicant for syngo.CT Single Source Dual Energy (Twin Beam)?

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 Single Source Dual Energy (Twin Beam)?

The FDA product code for syngo.CT Single Source Dual Energy (Twin Beam) is JAK.

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

K260055syngo.CT Brain Quantification K261696ACUNAV Luxera 4D ICE Catéter 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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Fuente oficial

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