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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 / K260746

510(k) cleared

S-scan Open (100001800)

Esaote, S.p.A. · Mar 27, 2026 · K260746

FDA cleared the S-scan Open (100001800) from Esaote, S.p.A. on Mar 27, 2026 under K260746, a special 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 Mar 6, 2026. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

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)), K251901 (Magnifico Open (100009900)), K253310 (7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)).

Questions & Answers

What did FDA clear under K260746?

K260746 is the FDA 510(k) for S-scan Open (100001800), submitted by Esaote, S.p.A.. FDA's decision date was Mar 27, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the S-scan Open (100001800)?

Esaote, S.p.A., based in Genoa, is the applicant of record for K260746.

How long did the K260746 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on Mar 27, 2026, 21 days later.

← All decisions in March 2026

Sources