CT Rembra RT; CT Areta RT; CT Rembra
K-Number: K252992 · 2026-03-23
Decision Date2026-03-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CT Rembra RT; CT Areta RT; CT Rembra is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-23 under approval 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. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K252992.
When was CT Rembra RT; CT Areta RT; CT Rembra approved by the FDA?
CT Rembra RT; CT Areta RT; CT Rembra received FDA 510(k) clearance on 2026-03-23, under approval number K252992.
What company makes CT Rembra RT; CT Areta RT; CT Rembra?
CT Rembra RT; CT Areta RT; CT Rembra is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
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.
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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.