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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 / September 2025 / K250040

510(k) cleared

uWS-Angio

Shanghai United Imaging Healthcare Co., Ltd. · Sep 12, 2025 · K250040

FDA cleared the uWS-Angio from Shanghai United Imaging Healthcare Co., Ltd. on Sep 12, 2025 under K250040, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 8, 2025. The decision came 247 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 K250040?

K250040 is the FDA 510(k) for uWS-Angio, submitted by Shanghai United Imaging Healthcare Co., Ltd.. FDA's decision date was Sep 12, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the uWS-Angio?

Shanghai United Imaging Healthcare Co., Ltd., based in Shanghai, is the applicant of record for K250040.

How long did the K250040 review take?

FDA received the submission on Jan 8, 2025 and issued its decision on Sep 12, 2025, 247 days later.

← All decisions in September 2025