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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 / K250839

510(k) cleared

Dental X-ray System

Changzhou Boen Zhongding Medical Technology Co., Ltd. · Jun 11, 2026 · K250839

FDA cleared the Dental X-ray System from Changzhou Boen Zhongding Medical Technology Co., Ltd. on Jun 11, 2026 under K250839, a traditional 510(k). The device falls under product code OAS, X-Ray, Tomography, Computed, Dental, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 20, 2025. The decision came 448 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 Changzhou Boen Zhongding Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250839?

K250839 is the FDA 510(k) for Dental X-ray System, submitted by Changzhou Boen Zhongding Medical Technology Co., Ltd.. FDA's decision date was Jun 11, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Dental X-ray System?

Changzhou Boen Zhongding Medical Technology Co., Ltd., based in Changzhou, is the applicant of record for K250839.

How long did the K250839 review take?

FDA received the submission on Mar 20, 2025 and issued its decision on Jun 11, 2026, 448 days later.

← All decisions in June 2026