FDA 510(k)

Ingenuity TF

K号: K172406 · 2017-10-06

申请人Philips Medical Systems (Cleveland), Inc.

决定日期2017-10-06

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Ingenuity TF is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172406. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ingenuity TF?

Ingenuity TF is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K172406.

When did Ingenuity TF receive FDA 510(k) clearance?

Ingenuity TF received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172406.

Who is the listed applicant for Ingenuity TF?

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

What is the FDA product code for Ingenuity TF?

The FDA product code for Ingenuity TF is KPS.

列明Philips Medical Systems (Cleveland), 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。

K171850Philips CT Big Bore K162838Philips iCT CT系统 K163711IQon Spectral CT K170086Pinnacle 放射治疗计划系统 K160743Philips Ingenuity CT K153444Philips 多层CT系统，配备低剂量CT肺癌

查看所有 7 个设备 →

相关器械（代码：KPS）

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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