FDA 510(k)

CT Rembra RT; CT Areta RT; CT Rembra

K号: K252992 · 2026-03-23

申请人Philips Healthcare (Suzhou) Co., Ltd.

决定日期2026-03-23

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

CT Rembra RT; CT Areta RT; CT Rembra is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-23 under 510(k) number K252992. 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 CT Rembra RT; CT Areta RT; CT Rembra?

CT Rembra RT; CT Areta RT; CT Rembra is a medical device that received FDA 510(k) clearance on 2026-03-23. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K252992.

When did CT Rembra RT; CT Areta RT; CT Rembra receive FDA 510(k) clearance?

CT Rembra RT; CT Areta RT; CT Rembra received FDA 510(k) clearance on 2026-03-23, under 510(k) number K252992.

Who is the listed applicant for CT Rembra RT; CT Areta RT; CT Rembra?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT Rembra RT; CT Areta RT; CT Rembra?

The FDA product code for CT Rembra RT; CT Areta RT; CT Rembra is JAK.

列明Philips Healthcare (Suzhou) Co., Ltd.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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