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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252992

510(k) cleared

CT Rembra RT; CT Areta RT; CT Rembra

Philips Healthcare (Suzhou) Co., Ltd. · Mar 23, 2026 · K252992

FDA cleared the CT Rembra RT; CT Areta RT; CT Rembra from Philips Healthcare (Suzhou) Co., Ltd. on Mar 23, 2026 under K252992, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 18, 2025. The decision came 186 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Healthcare (Suzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K260519 (Smart Fit TorsoCardiac 1.5T).

Questions & Answers

What did FDA clear under K252992?

K252992 is the FDA 510(k) for CT Rembra RT; CT Areta RT; CT Rembra, submitted by Philips Healthcare (Suzhou) Co., Ltd.. FDA's decision date was Mar 23, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the CT Rembra RT; CT Areta RT; CT Rembra?

Philips Healthcare (Suzhou) Co., Ltd., based in Suzhou, is the applicant of record for K252992.

How long did the K252992 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Mar 23, 2026, 186 days later.

← All decisions in March 2026

Sources