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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 / November 2025 / K251842

510(k) cleared

Dental Computed Tomography X-ray System

Fussen Technology Co., Ltd. · Nov 13, 2025 · K251842

FDA cleared the Dental Computed Tomography X-ray System from Fussen Technology Co., Ltd. on Nov 13, 2025 under K251842, 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 Jun 16, 2025. The decision came 150 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 Fussen Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251842?

K251842 is the FDA 510(k) for Dental Computed Tomography X-ray System, submitted by Fussen Technology Co., Ltd.. FDA's decision date was Nov 13, 2025, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Dental Computed Tomography X-ray System?

Fussen Technology Co., Ltd., based in Shenzhen, is the applicant of record for K251842.

How long did the K251842 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Nov 13, 2025, 150 days later.

← All decisions in November 2025