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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K253726

510(k) cleared

uAngio AVIVA CX

Shanghai United Imaging Healthcare Co., Ltd. · Aug 21, 2026 · K253726

FDA cleared the uAngio AVIVA CX from Shanghai United Imaging Healthcare Co., Ltd. on Aug 21, 2026 under K253726, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 24, 2025. The decision came 270 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 K253726?

K253726 is the FDA 510(k) for uAngio AVIVA CX, submitted by Shanghai United Imaging Healthcare Co., Ltd.. FDA's decision date was Aug 21, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the uAngio AVIVA CX?

Shanghai United Imaging Healthcare Co., Ltd., based in Shanghai, is the applicant of record for K253726.

How long did the K253726 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Aug 21, 2026, 270 days later.

← All decisions in August 2026