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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 / June 2026 / K253058

510(k) cleared

Portable DR Imaging System

Shantou Institute of Ultrasonic Instruments Co., Ltd. · Jun 18, 2026 · K253058

FDA cleared the Portable DR Imaging System from Shantou Institute of Ultrasonic Instruments Co., Ltd. on Jun 18, 2026 under K253058, a traditional 510(k). The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 22, 2025. The decision came 269 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253058?

K253058 is the FDA 510(k) for Portable DR Imaging System, submitted by Shantou Institute of Ultrasonic Instruments Co., Ltd.. FDA's decision date was Jun 18, 2026, under product code IZL (System, X-Ray, Mobile).

Who makes the Portable DR Imaging System?

Shantou Institute of Ultrasonic Instruments Co., Ltd., based in Shantou, is the applicant of record for K253058.

How long did the K253058 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 18, 2026, 269 days later.

← All decisions in June 2026