FDA 510(k)

Sumitomo Proton Therapy System

Número K: K160612 · 2016-08-17

RequerenteSumitomo Heavy Industries, Ltd.

Data da decisão2016-08-17

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sumitomo Proton Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Heavy Industries, Ltd.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K160612. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sumitomo Proton Therapy System?

Sumitomo Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Sumitomo Heavy Industries, Ltd.. The 510(k) number is K160612.

When did Sumitomo Proton Therapy System receive FDA 510(k) clearance?

Sumitomo Proton Therapy System received FDA 510(k) clearance on 2016-08-17, under 510(k) number K160612.

Who is the listed applicant for Sumitomo Proton Therapy System?

The FDA 510(k) record lists Sumitomo Heavy Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sumitomo Proton Therapy System?

The FDA product code for Sumitomo Proton Therapy System is LHN.

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