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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 / K253163

510(k) cleared

EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Ever Fortune.Ai, Co., Ltd. · Apr 22, 2026 · K253163

FDA cleared the EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) from Ever Fortune.Ai, Co., Ltd. on Apr 22, 2026 under K253163, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 26, 2025. The decision came 208 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: K251306 (Seg Pro V3 (RT-300)).

Questions & Answers

What did FDA clear under K253163?

K253163 is the FDA 510(k) for EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100), submitted by Ever Fortune.Ai, Co., Ltd.. FDA's decision date was Apr 22, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)?

Ever Fortune.Ai, Co., Ltd., based in Taichung City, is the applicant of record for K253163.

How long did the K253163 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Apr 22, 2026, 208 days later.

← All decisions in April 2026

Sources