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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 / April 2026 / K260462

510(k) cleared

RCT800

Ray Co., Ltd. · Apr 9, 2026 · K260462

FDA cleared the RCT800 from Ray Co., Ltd. on Apr 9, 2026 under K260462, a special 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 Feb 12, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Ray Co., Ltd. has one other decision in the tracker over the last 12 months: K251798 (RCT700).

Questions & Answers

What did FDA clear under K260462?

K260462 is the FDA 510(k) for RCT800, submitted by Ray Co., Ltd.. FDA's decision date was Apr 9, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the RCT800?

Ray Co., Ltd., based in Yongin-Si, is the applicant of record for K260462.

How long did the K260462 review take?

FDA received the submission on Feb 12, 2026 and issued its decision on Apr 9, 2026, 56 days later.

← All decisions in April 2026