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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 / K260662

510(k) cleared

Dental Cone Beam Computed Tomography System

Yofo Medical Technology Co., Ltd. · Jun 4, 2026 · K260662

FDA cleared the Dental Cone Beam Computed Tomography System from Yofo Medical Technology Co., Ltd. on Jun 4, 2026 under K260662, a special 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 2, 2026. The decision came 94 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 Yofo Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260662?

K260662 is the FDA 510(k) for Dental Cone Beam Computed Tomography System, submitted by Yofo Medical Technology Co., Ltd.. FDA's decision date was Jun 4, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Dental Cone Beam Computed Tomography System?

Yofo Medical Technology Co., Ltd., based in Hefei, is the applicant of record for K260662.

How long did the K260662 review take?

FDA received the submission on Mar 2, 2026 and issued its decision on Jun 4, 2026, 94 days later.

← All decisions in June 2026