FDA 510(k)

CT TrueView

K号: K160147 · 2016-08-10

申请人Philips Medical Systems Nederland B.V.

决定日期2016-08-10

产品代码OWB

咨询委员会RA

决定Substantially Equivalent

器械摘要

CT TrueView is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K160147. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CT TrueView?

CT TrueView is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K160147.

When did CT TrueView receive FDA 510(k) clearance?

CT TrueView received FDA 510(k) clearance on 2016-08-10, under 510(k) number K160147.

Who is the listed applicant for CT TrueView?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT TrueView?

The FDA product code for CT TrueView is OWB.

列明Philips Medical Systems Nederland B.V.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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