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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 / April 2026 / K253288

510(k) cleared

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Esaote, S.p.A. · Apr 6, 2026 · K253288

FDA cleared the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) from Esaote, S.p.A. on Apr 6, 2026 under K253288, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 189 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)), 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 K253288?

K253288 is the FDA 510(k) for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85), submitted by Esaote, S.p.A.. FDA's decision date was Apr 6, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

Esaote, S.p.A., based in Genoa, is the applicant of record for K253288.

How long did the K253288 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Apr 6, 2026, 189 days later.

← All decisions in April 2026

Sources