FDA 510(k)

ECHELON Oval V 5.1 MRI System

Número K: K153547 · 2016-03-31

RequerenteHitachi Medical Systems America, Inc.

Data da decisão2016-03-31

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ECHELON Oval V 5.1 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K153547. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ECHELON Oval V 5.1 MRI System?

ECHELON Oval V 5.1 MRI System is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K153547.

When did ECHELON Oval V 5.1 MRI System receive FDA 510(k) clearance?

ECHELON Oval V 5.1 MRI System received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153547.

Who is the listed applicant for ECHELON Oval V 5.1 MRI System?

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

What is the FDA product code for ECHELON Oval V 5.1 MRI System?

The FDA product code for ECHELON Oval V 5.1 MRI System is LNH.

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Outros registros que listam Hitachi Medical Systems America, Inc. como candidato(a)

K163528HITACHI Supria Whole-body X-ray CT System Phase 3 K162079TRILLIUM Oval Head Coil 32 K161748SUPRIA w/guideShot Option K160152Trillium Oval V 5.1 MRI System

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Fonte oficial

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