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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 / January 2026 / K251306

510(k) cleared

Seg Pro V3 (RT-300)

Ever Fortune.Ai, Co., Ltd. · Jan 28, 2026 · K251306

FDA cleared the Seg Pro V3 (RT-300) from Ever Fortune.Ai, Co., Ltd. on Jan 28, 2026 under K251306, a traditional 510(k). The device falls under product code QKB, Radiological Image Processing Software For Radiation Therapy, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 28, 2025. The decision came 275 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ever Fortune.Ai, Co., Ltd. has one other decision in the tracker over the last 12 months: K253163 (EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)).

Questions & Answers

What did FDA clear under K251306?

K251306 is the FDA 510(k) for Seg Pro V3 (RT-300), submitted by Ever Fortune.Ai, Co., Ltd.. FDA's decision date was Jan 28, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the Seg Pro V3 (RT-300)?

Ever Fortune.Ai, Co., Ltd., based in Taichung City, is the applicant of record for K251306.

How long did the K251306 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Jan 28, 2026, 275 days later.

← All decisions in January 2026

Sources