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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 / May 2026 / K260111

510(k) cleared

Palmtop Ultrasound Diagnostic System (MT10P/MT10)

Mytech Intelligence (Shenzhen) Co., Ltd. · May 14, 2026 · K260111

FDA cleared the Palmtop Ultrasound Diagnostic System (MT10P/MT10) from Mytech Intelligence (Shenzhen) Co., Ltd. on May 14, 2026 under K260111, 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 Jan 14, 2026. The decision came 120 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 Mytech Intelligence (Shenzhen) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260111?

K260111 is the FDA 510(k) for Palmtop Ultrasound Diagnostic System (MT10P/MT10), submitted by Mytech Intelligence (Shenzhen) Co., Ltd.. FDA's decision date was May 14, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Palmtop Ultrasound Diagnostic System (MT10P/MT10)?

Mytech Intelligence (Shenzhen) Co., Ltd., based in Shenzhen, is the applicant of record for K260111.

How long did the K260111 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on May 14, 2026, 120 days later.

← All decisions in May 2026