FDA 510(k)

Xario 100 诊断超声系统，V5.0

K号: K162187 · 2016-09-30

决定日期2016-09-30

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Xario 100 Diagnostic Ultrasound System, V5.0 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 2016-09-30 under 510(k) number K162187. 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 Xario 100 Diagnostic Ultrasound System, V5.0?

Xario 100 Diagnostic Ultrasound System, V5.0 is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K162187.

When did Xario 100 Diagnostic Ultrasound System, V5.0 receive FDA 510(k) clearance?

Xario 100 Diagnostic Ultrasound System, V5.0 received FDA 510(k) clearance on 2016-09-30, under 510(k) number K162187.

Who is the listed applicant for Xario 100 Diagnostic Ultrasound System, V5.0?

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 Xario 100 Diagnostic Ultrasound System, V5.0?

The FDA product code for Xario 100 Diagnostic Ultrasound System, V5.0 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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