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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 / K251004

510(k) cleared

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

Hefei Chimed Intelligent Machine Co., Ltd. · Nov 6, 2025 · K251004

FDA cleared the Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) from Hefei Chimed Intelligent Machine Co., Ltd. on Nov 6, 2025 under K251004, a traditional 510(k). The device falls under product code OXO, Image-Intensified Fluoroscopic X-Ray System, Mobile, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 1, 2025. The decision came 219 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hefei Chimed Intelligent Machine Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251004?

K251004 is the FDA 510(k) for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M), submitted by Hefei Chimed Intelligent Machine Co., Ltd.. FDA's decision date was Nov 6, 2025, under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile).

Who makes the Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

Hefei Chimed Intelligent Machine Co., Ltd., based in Hefei, is the applicant of record for K251004.

How long did the K251004 review take?

FDA received the submission on Apr 1, 2025 and issued its decision on Nov 6, 2025, 219 days later.

← All decisions in November 2025