FDA 510(k)

Philips 多层CT系统，配备低剂量CT肺癌

K号: K153444 · 2016-04-08

申请人Philips Medical Systems (Cleveland), Inc.

决定日期2016-04-08

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

Philips Multislice CT System with Low Dose CT Lung Cancer 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 2016-04-08 under 510(k) number K153444. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Philips Multislice CT System with Low Dose CT Lung Cancer?

Philips Multislice CT System with Low Dose CT Lung Cancer is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K153444.

When did Philips Multislice CT System with Low Dose CT Lung Cancer receive FDA 510(k) clearance?

Philips Multislice CT System with Low Dose CT Lung Cancer received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153444.

Who is the listed applicant for Philips Multislice CT System with Low Dose CT Lung Cancer?

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 Philips Multislice CT System with Low Dose CT Lung Cancer?

The FDA product code for Philips Multislice CT System with Low Dose CT Lung Cancer is JAK.

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。

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官方来源

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