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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 / K251901

510(k) cleared

Magnifico Open (100009900)

Esaote, S.p.A. · Mar 5, 2026 · K251901

FDA cleared the Magnifico Open (100009900) from Esaote, S.p.A. on Mar 5, 2026 under K251901, 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 Jun 20, 2025. The decision came 258 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: K261331 (I-Genius (100019400)), K253288 (6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)), K260746 (S-scan Open (100001800)), K253310 (7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)).

Questions & Answers

What did FDA clear under K251901?

K251901 is the FDA 510(k) for Magnifico Open (100009900), submitted by Esaote, S.p.A.. FDA's decision date was Mar 5, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Magnifico Open (100009900)?

Esaote, S.p.A., based in Genoa, is the applicant of record for K251901.

How long did the K251901 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Mar 5, 2026, 258 days later.

← All decisions in March 2026

Sources