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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 / March 2026 / K252261

510(k) cleared

InferCare RECIST

Beijing Infervision Healthcare Medical Technology Co., Ltd. · Mar 13, 2026 · K252261

FDA cleared the InferCare RECIST from Beijing Infervision Healthcare Medical Technology Co., Ltd. on Mar 13, 2026 under K252261, 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 Jul 21, 2025. The decision came 235 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), K250237 (InferOperate Suite).

Questions & Answers

What did FDA clear under K252261?

K252261 is the FDA 510(k) for InferCare RECIST, submitted by Beijing Infervision Healthcare Medical Technology Co., Ltd.. FDA's decision date was Mar 13, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the InferCare RECIST?

Beijing Infervision Healthcare Medical Technology Co., Ltd., based in Beijing, is the applicant of record for K252261.

How long did the K252261 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Mar 13, 2026, 235 days later.

← All decisions in March 2026

Sources