FDA 510(k)

Trillium椭圆形V 5.1磁共振成像系统

K号: K160152 · 2016-05-20

申请人Hitachi Medical Systems America, Inc.

决定日期2016-05-20

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

Trillium Oval V 5.1 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160152. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trillium Oval V 5.1 MRI System?

Trillium Oval V 5.1 MRI System is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K160152.

When did Trillium Oval V 5.1 MRI System receive FDA 510(k) clearance?

Trillium Oval V 5.1 MRI System received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160152.

Who is the listed applicant for Trillium Oval V 5.1 MRI System?

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

What is the FDA product code for Trillium Oval V 5.1 MRI System?

The FDA product code for Trillium Oval V 5.1 MRI System is LNH.

列明Hitachi Medical Systems America, Inc.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。

K163528日立 Supria 全身 X 射线 CT 系统第三阶段 K162079TRILLIUM 椭圆形头线圈 32 K161748SUPRIA 带guideShot 选项 K153547ECHELON 椭圆形 V 5.1 MRI 系统

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。