FDA 510(k)

Sistema de Ultrassonografia Diagnóstica ARIETTA Prologue e Transdutores

Número K: K162902 · 2016-12-15

Data da decisão2016-12-15

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K162902. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Hitachi , Ltd.. The 510(k) number is K162902.

When did ARIETTA Prologue Diagnostic Ultrasound system and Transducers receive FDA 510(k) clearance?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162902.

Who is the listed applicant for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

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

What is the FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

The FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers is IYN.

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Fonte oficial

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