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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 / K250791

510(k) cleared

ASUS Ultrasound Imaging System (LU800 series)

Asustek Computer, Inc. · Dec 4, 2025 · K250791

FDA cleared the ASUS Ultrasound Imaging System (LU800 series) from Asustek Computer, Inc. on Dec 4, 2025 under K250791, 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 Mar 14, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Asustek Computer, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250791?

K250791 is the FDA 510(k) for ASUS Ultrasound Imaging System (LU800 series), submitted by Asustek Computer, Inc.. FDA's decision date was Dec 4, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the ASUS Ultrasound Imaging System (LU800 series)?

Asustek Computer, Inc., based in Taipei, is the applicant of record for K250791.

How long did the K250791 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Dec 4, 2025, 265 days later.

← All decisions in December 2025