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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 / December 2025 / K250914

510(k) cleared

MediAI-BA

Crescom Co., Ltd. · Dec 18, 2025 · K250914

FDA cleared the MediAI-BA from Crescom Co., Ltd. on Dec 18, 2025 under K250914, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 27, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Crescom Co., Ltd. has one other decision in the tracker over the last 12 months: K253172 (MediAI-OA).

Questions & Answers

What did FDA clear under K250914?

K250914 is the FDA 510(k) for MediAI-BA, submitted by Crescom Co., Ltd.. FDA's decision date was Dec 18, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the MediAI-BA?

Crescom Co., Ltd., based in Seongnam-Si, is the applicant of record for K250914.

How long did the K250914 review take?

FDA received the submission on Mar 27, 2025 and issued its decision on Dec 18, 2025, 266 days later.

← All decisions in December 2025

Sources