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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 / K252353

510(k) cleared

myray ProXIma X6

Cefla S.C. · Mar 10, 2026 · K252353

FDA cleared the myray ProXIma X6 from Cefla S.C. on Mar 10, 2026 under K252353, 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 Jul 29, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cefla S.C. has one other decision in the tracker over the last 12 months: K260716 (Neowise).

Questions & Answers

What did FDA clear under K252353?

K252353 is the FDA 510(k) for myray ProXIma X6, submitted by Cefla S.C.. FDA's decision date was Mar 10, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the myray ProXIma X6?

Cefla S.C., based in Imola (Bo), is the applicant of record for K252353.

How long did the K252353 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Mar 10, 2026, 224 days later.

← All decisions in March 2026