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FDA 510(k)

CT Rembra RT; CT Areta RT; CT Rembra

K-Number: K252992 · 2026-03-23

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2026-03-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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