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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 / February 2026 / K252084

510(k) cleared

AI4CMR v2.0

Ai4medimaging Medical Solutions S.A. · Feb 11, 2026 · K252084

FDA cleared the AI4CMR v2.0 from Ai4medimaging Medical Solutions S.A. on Feb 11, 2026 under K252084, a special 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 2, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ai4medimaging Medical Solutions S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252084?

K252084 is the FDA 510(k) for AI4CMR v2.0, submitted by Ai4medimaging Medical Solutions S.A.. FDA's decision date was Feb 11, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AI4CMR v2.0?

Ai4medimaging Medical Solutions S.A., based in Braga, is the applicant of record for K252084.

How long did the K252084 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Feb 11, 2026, 224 days later.

← All decisions in February 2026