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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 / November 2025 / K251798

510(k) cleared

RCT700

Ray Co., Ltd. · Nov 25, 2025 · K251798

FDA cleared the RCT700 from Ray Co., Ltd. on Nov 25, 2025 under K251798, a traditional 510(k). The device falls under product code OAS, X-Ray, Tomography, Computed, Dental, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 12, 2025. The decision came 166 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ray Co., Ltd. has one other decision in the tracker over the last 12 months: K260462 (RCT800).

Questions & Answers

What did FDA clear under K251798?

K251798 is the FDA 510(k) for RCT700, submitted by Ray Co., Ltd.. FDA's decision date was Nov 25, 2025, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the RCT700?

Ray Co., Ltd., based in Yongin-Si, is the applicant of record for K251798.

How long did the K251798 review take?

FDA received the submission on Jun 12, 2025 and issued its decision on Nov 25, 2025, 166 days later.

← All decisions in November 2025