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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 / December 2025 / K251416

510(k) cleared

UltraSight Guidance

Ultrasight , Ltd. · Dec 17, 2025 · K251416

FDA cleared the UltraSight Guidance from Ultrasight , Ltd. on Dec 17, 2025 under K251416, a traditional 510(k). The device falls under product code QJU, Image Acquisition And/Or Optimization Guided By Artificial Intelligence, regulated at 21 CFR 892.2100 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 7, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ultrasight , Ltd. has one other decision in the tracker over the last 12 months: K252235 (PVAD IQ Software).

Questions & Answers

What did FDA clear under K251416?

K251416 is the FDA 510(k) for UltraSight Guidance, submitted by Ultrasight , Ltd.. FDA's decision date was Dec 17, 2025, under product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence).

Who makes the UltraSight Guidance?

Ultrasight , Ltd., based in Ness Ziona, is the applicant of record for K251416.

How long did the K251416 review take?

FDA received the submission on May 7, 2025 and issued its decision on Dec 17, 2025, 224 days later.

← All decisions in December 2025

Sources