FDA 510(k)

Real Time Image Gating System for Proton Beam Therapy Systems

Número K: K171049 · 2017-12-26

Data da decisão2017-12-26

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Real Time Image Gating System for Proton Beam Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Healthcare. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K171049. 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 Real Time Image Gating System for Proton Beam Therapy Systems?

Real Time Image Gating System for Proton Beam Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Hitachi, Ltd. Healthcare. The 510(k) number is K171049.

When did Real Time Image Gating System for Proton Beam Therapy Systems receive FDA 510(k) clearance?

Real Time Image Gating System for Proton Beam Therapy Systems received FDA 510(k) clearance on 2017-12-26, under 510(k) number K171049.

Who is the listed applicant for Real Time Image Gating System for Proton Beam Therapy Systems?

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

What is the FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems?

The FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems is LHN.

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