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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 / November 2025 / K253310

510(k) cleared

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

Esaote, S.p.A. · Nov 25, 2025 · K253310

FDA cleared the 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) from Esaote, S.p.A. on Nov 25, 2025 under K253310, a special 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 57 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)), K260746 (S-scan Open (100001800)), K251901 (Magnifico Open (100009900)).

Questions & Answers

What did FDA clear under K253310?

K253310 is the FDA 510(k) for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30), submitted by Esaote, S.p.A.. FDA's decision date was Nov 25, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)?

Esaote, S.p.A., based in Genoa, is the applicant of record for K253310.

How long did the K253310 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Nov 25, 2025, 57 days later.

← All decisions in November 2025

Sources