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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 / July 2026 / K261288

510(k) cleared

Handheld Ultrasound Scanner

IMGFAX CO., LTD. · Jul 30, 2026 · K261288

FDA cleared the Handheld Ultrasound Scanner from IMGFAX CO., LTD. on Jul 30, 2026 under K261288, 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 Apr 20, 2026. The decision came 101 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 IMGFAX CO., LTD. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261288?

K261288 is the FDA 510(k) for Handheld Ultrasound Scanner, submitted by IMGFAX CO., LTD.. FDA's decision date was Jul 30, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Handheld Ultrasound Scanner?

IMGFAX CO., LTD., based in Foshan, is the applicant of record for K261288.

How long did the K261288 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Jul 30, 2026, 101 days later.

← All decisions in July 2026