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THE TAPE

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 / K252000

510(k) cleared

uDR Arria & uDR Aris

Shanghai United Imaging Healthcare Co., Ltd. · Nov 26, 2025 · K252000

FDA cleared the uDR Arria & uDR Aris from Shanghai United Imaging Healthcare Co., Ltd. on Nov 26, 2025 under K252000, 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 Jun 27, 2025. The decision came 152 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 K252000?

K252000 is the FDA 510(k) for uDR Arria & uDR Aris, submitted by Shanghai United Imaging Healthcare Co., Ltd.. FDA's decision date was Nov 26, 2025, under product code KPR (System, X-Ray, Stationary).

Who makes the uDR Arria & uDR Aris?

Shanghai United Imaging Healthcare Co., Ltd., based in Shanghai, is the applicant of record for K252000.

How long did the K252000 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Nov 26, 2025, 152 days later.

← All decisions in November 2025