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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 / March 2026 / K252110

510(k) cleared

Dental X-RAY Unit (AJX200)

Guangzhou Ajax Medical Equipment Co., Ltd. · Mar 12, 2026 · K252110

FDA cleared the Dental X-RAY Unit (AJX200) from Guangzhou Ajax Medical Equipment Co., Ltd. on Mar 12, 2026 under K252110, a traditional 510(k). The device falls under product code EHD, Unit, X-Ray, Extraoral With Timer, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 7, 2025. The decision came 248 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 Guangzhou Ajax Medical Equipment Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252110?

K252110 is the FDA 510(k) for Dental X-RAY Unit (AJX200), submitted by Guangzhou Ajax Medical Equipment Co., Ltd.. FDA's decision date was Mar 12, 2026, under product code EHD (Unit, X-Ray, Extraoral With Timer).

Who makes the Dental X-RAY Unit (AJX200)?

Guangzhou Ajax Medical Equipment Co., Ltd., based in Guangzhou, is the applicant of record for K252110.

How long did the K252110 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Mar 12, 2026, 248 days later.

← All decisions in March 2026