FDA 510(k)

Lumify 超声系统

K号: K162549 · 2016-10-03

决定日期2016-10-03

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Lumify Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K162549. 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 Lumify Ultrasound System?

Lumify Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is Philips Health Care. The 510(k) number is K162549.

When did Lumify Ultrasound System receive FDA 510(k) clearance?

Lumify Ultrasound System received FDA 510(k) clearance on 2016-10-03, under 510(k) number K162549.

Who is the listed applicant for Lumify Ultrasound System?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumify Ultrasound System?

The FDA product code for Lumify Ultrasound System is IYN.

列明Philips Health Care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。

K2013523D 自动LAA K200974QLAB高级量化软件 K200179Collaboration Live K191647QLAB高级量化软件 K192226Lumify 诊断超声系统 K190913QLAB高级量化软件 13

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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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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。