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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 / September 2025 / K252371

510(k) cleared

uMR 680

Shanghai United Imaging Healthcare Co., Ltd. · Sep 25, 2025 · K252371

FDA cleared the uMR 680 from Shanghai United Imaging Healthcare Co., Ltd. on Sep 25, 2025 under K252371, a special 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 30, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Shanghai United Imaging Healthcare Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K261427 (uMI Panvivo (uMI Panvivo M)), K260113 (uMR Astra), K253077 (uOmnispace.MR), K260524 (uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)).

Questions & Answers

What did FDA clear under K252371?

K252371 is the FDA 510(k) for uMR 680, submitted by Shanghai United Imaging Healthcare Co., Ltd.. FDA's decision date was Sep 25, 2025, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the uMR 680?

Shanghai United Imaging Healthcare Co., Ltd., based in Shanghai, is the applicant of record for K252371.

How long did the K252371 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Sep 25, 2025, 57 days later.

← All decisions in September 2025