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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 / K253935

510(k) cleared

medXion NEXUS

medXion Technologies, Inc. · May 15, 2026 · K253935

FDA cleared the medXion NEXUS from medXion Technologies, Inc. on May 15, 2026 under K253935, 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 Dec 9, 2025. The decision came 157 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 medXion Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253935?

K253935 is the FDA 510(k) for medXion NEXUS, submitted by medXion Technologies, Inc.. FDA's decision date was May 15, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the medXion NEXUS?

medXion Technologies, Inc., based in Tokyo, is the applicant of record for K253935.

How long did the K253935 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on May 15, 2026, 157 days later.

← All decisions in May 2026