FDA 510(k)

Synapse 3D Perfusion Analysis

Número K: K162287 · 2017-04-06

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2017-04-06

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synapse 3D Perfusion Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162287. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synapse 3D Perfusion Analysis?

Synapse 3D Perfusion Analysis is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162287.

When did Synapse 3D Perfusion Analysis receive FDA 510(k) clearance?

Synapse 3D Perfusion Analysis received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162287.

Who is the listed applicant for Synapse 3D Perfusion Analysis?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapse 3D Perfusion Analysis?

The FDA product code for Synapse 3D Perfusion Analysis is LLZ.

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Fonte oficial

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