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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 / July 2026 / K261331

510(k) cleared

I-Genius (100019400)

Esaote, S.p.A. · Jul 31, 2026 · K261331

FDA cleared the I-Genius (100019400) from Esaote, S.p.A. on Jul 31, 2026 under K261331, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 22, 2026. The decision came 100 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Esaote, S.p.A. has 4 other decisions in the tracker over the last 12 months: K253288 (6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)), K260746 (S-scan Open (100001800)), K251901 (Magnifico Open (100009900)), K253310 (7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)).

Questions & Answers

What did FDA clear under K261331?

K261331 is the FDA 510(k) for I-Genius (100019400), submitted by Esaote, S.p.A.. FDA's decision date was Jul 31, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the I-Genius (100019400)?

Esaote, S.p.A., based in Genoa, is the applicant of record for K261331.

How long did the K261331 review take?

FDA received the submission on Apr 22, 2026 and issued its decision on Jul 31, 2026, 100 days later.

← All decisions in July 2026

Sources