FDA 510(k)

Aplio i900/i800/i700 诊断超声系统，V2.1

K号: K163702 · 2017-05-30

决定日期2017-05-30

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K163702. 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 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1?

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K163702.

When did Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 receive FDA 510(k) clearance?

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 received FDA 510(k) clearance on 2017-05-30, under 510(k) number K163702.

Who is the listed applicant for Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1?

The FDA product code for Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 is IYN.

列明Toshibamedical Systems Corporation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。

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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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