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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 / April 2026 / K260524

510(k) cleared

uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Shanghai United Imaging Healthcare Co., Ltd. · Apr 3, 2026 · K260524

FDA cleared the uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) from Shanghai United Imaging Healthcare Co., Ltd. on Apr 3, 2026 under K260524, a traditional 510(k). The device falls under product code KPS, System, Tomography, Computed, Emission, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 17, 2026. The decision came 45 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), K253564 (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 K260524?

K260524 is the FDA 510(k) for uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES), submitted by Shanghai United Imaging Healthcare Co., Ltd.. FDA's decision date was Apr 3, 2026, under product code KPS (System, Tomography, Computed, Emission).

Who makes the uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)?

Shanghai United Imaging Healthcare Co., Ltd., based in Shanghai, is the applicant of record for K260524.

How long did the K260524 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Apr 3, 2026, 45 days later.

← All decisions in April 2026