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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 / K250237

510(k) cleared

InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd. · Sep 15, 2025 · K250237

FDA cleared the InferOperate Suite from Beijing Infervision Healthcare Medical Technology Co., Ltd. on Sep 15, 2025 under K250237, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 27, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Infervision Healthcare Medical Technology Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260973 (InferOperate Suite), K252261 (InferCare RECIST).

Questions & Answers

What did FDA clear under K250237?

K250237 is the FDA 510(k) for InferOperate Suite, submitted by Beijing Infervision Healthcare Medical Technology Co., Ltd.. FDA's decision date was Sep 15, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the InferOperate Suite?

Beijing Infervision Healthcare Medical Technology Co., Ltd., based in Beijing, is the applicant of record for K250237.

How long did the K250237 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Sep 15, 2025, 231 days later.

← All decisions in September 2025

Sources