FDA 510(k)

syngo.via RT Image Suite

Número K: K162370 · 2016-10-25

RequerenteSiemens Medical Solutions USA, Inc.

Data da decisão2016-10-25

Código do produtoMUJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

syngo.via RT Image Suite 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 2016-10-25 under 510(k) number K162370. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the syngo.via RT Image Suite?

syngo.via RT Image Suite is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K162370.

When did syngo.via RT Image Suite receive FDA 510(k) clearance?

syngo.via RT Image Suite received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162370.

Who is the listed applicant for syngo.via RT Image Suite?

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.via RT Image Suite?

The FDA product code for syngo.via RT Image Suite is MUJ.

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Fonte oficial

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