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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 / K260595

510(k) cleared

Sonosite iLOOK Ultrasound System

FUJIFILM Sonosite, Inc. · Mar 10, 2026 · K260595

FDA cleared the Sonosite iLOOK Ultrasound System from FUJIFILM Sonosite, Inc. on Mar 10, 2026 under K260595, 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 Feb 23, 2026. The decision came 15 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: K253448 (Sonosite MT Ultrasound System).

Questions & Answers

What did FDA clear under K260595?

K260595 is the FDA 510(k) for Sonosite iLOOK Ultrasound System, submitted by FUJIFILM Sonosite, Inc.. FDA's decision date was Mar 10, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Sonosite iLOOK Ultrasound System?

FUJIFILM Sonosite, Inc., based in Bothell, WA, is the applicant of record for K260595.

How long did the K260595 review take?

FDA received the submission on Feb 23, 2026 and issued its decision on Mar 10, 2026, 15 days later.

← All decisions in March 2026

Sources