FDA 510(k)

ARIETTA Prologue 诊断超声系统和探头

K号: K162902 · 2016-12-15

决定日期2016-12-15

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Hitachi , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K201042PROBEAT-CR K191801PROBEAT-CR K172087SANGRAY K163505ARIETTA PRECISION K162583ALOKA LISENDO 880 K161163PROBEAT-V 质子束治疗系统带 X 射线限制附件

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相关器械（代码：IYN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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