FDA 510(k)

ARIETTA 50

K号: K190248 · 2019-04-02

决定日期2019-04-02

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

ARIETTA 50 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-04-02 under 510(k) number K190248. 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 50?

ARIETTA 50 is a medical device that received FDA 510(k) clearance on 2019-04-02. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K190248.

When did ARIETTA 50 receive FDA 510(k) clearance?

ARIETTA 50 received FDA 510(k) clearance on 2019-04-02, under 510(k) number K190248.

Who is the listed applicant for ARIETTA 50?

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

What is the FDA product code for ARIETTA 50?

The FDA product code for ARIETTA 50 is IYN.

列明Hitachi Healthcare Americas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。

K211406OASIS MRI系统 K202422Arietta 65 K202030OASIS MRI系统 K200498SCENARIA View K192851OASIS MRI系统 K190841SCENARIA View

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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。

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。