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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 / May 2026 / K260367

510(k) cleared

Portable Dental X-ray System Model PDX nova

PDX Co., Ltd. · May 27, 2026 · K260367

FDA cleared the Portable Dental X-ray System Model PDX nova from PDX Co., Ltd. on May 27, 2026 under K260367, 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 Feb 4, 2026. The decision came 112 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 PDX Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260367?

K260367 is the FDA 510(k) for Portable Dental X-ray System Model PDX nova, submitted by PDX Co., Ltd.. FDA's decision date was May 27, 2026, under product code EHD (Unit, X-Ray, Extraoral With Timer).

Who makes the Portable Dental X-ray System Model PDX nova?

PDX Co., Ltd., based in Anyang-Si, Gyeonggi-Do, is the applicant of record for K260367.

How long did the K260367 review take?

FDA received the submission on Feb 4, 2026 and issued its decision on May 27, 2026, 112 days later.

← All decisions in May 2026