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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 / K253269

510(k) cleared

OEC One CFD

Ge Hualun Medical Systems Co. , Ltd. · Nov 26, 2025 · K253269

FDA cleared the OEC One CFD from Ge Hualun Medical Systems Co. , Ltd. on Nov 26, 2025 under K253269, 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 Sep 29, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ge Hualun Medical Systems Co. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253269?

K253269 is the FDA 510(k) for OEC One CFD, submitted by Ge Hualun Medical Systems Co. , Ltd.. FDA's decision date was Nov 26, 2025, under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile).

Who makes the OEC One CFD?

Ge Hualun Medical Systems Co. , Ltd., based in Beijing, is the applicant of record for K253269.

How long did the K253269 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Nov 26, 2025, 58 days later.

← All decisions in November 2025