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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 / K253448

510(k) cleared

Sonosite MT Ultrasound System

FUJIFILM Sonosite, Inc. · Nov 3, 2025 · K253448

FDA cleared the Sonosite MT Ultrasound System from FUJIFILM Sonosite, Inc. on Nov 3, 2025 under K253448, a traditional 510(k) reviewed through the Third Party Review Program. 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 Oct 2, 2025. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

FUJIFILM Sonosite, Inc. has one other decision in the tracker over the last 12 months: K260595 (Sonosite iLOOK Ultrasound System).

Questions & Answers

What did FDA clear under K253448?

K253448 is the FDA 510(k) for Sonosite MT Ultrasound System, submitted by FUJIFILM Sonosite, Inc.. FDA's decision date was Nov 3, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Sonosite MT Ultrasound System?

FUJIFILM Sonosite, Inc., based in Bothell, WA, is the applicant of record for K253448.

How long did the K253448 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Nov 3, 2025, 32 days later.

← All decisions in November 2025

Sources