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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 / K251167

510(k) cleared

uDR Aurora CX

Shanghai United Imaging Healthcare Co., Ltd. · Sep 19, 2025 · K251167

FDA cleared the uDR Aurora CX from Shanghai United Imaging Healthcare Co., Ltd. on Sep 19, 2025 under K251167, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 15, 2025. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K251167?

K251167 is the FDA 510(k) for uDR Aurora CX, submitted by Shanghai United Imaging Healthcare Co., Ltd.. FDA's decision date was Sep 19, 2025, under product code KPR (System, X-Ray, Stationary).

Who makes the uDR Aurora CX?

Shanghai United Imaging Healthcare Co., Ltd., based in Shanghai, is the applicant of record for K251167.

How long did the K251167 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Sep 19, 2025, 157 days later.

← All decisions in September 2025