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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 / July 2026 / K253800

510(k) cleared

0909FCE, 0909FCE-HS

Rayence Co., Ltd. · Jul 31, 2026 · K253800

FDA cleared the 0909FCE, 0909FCE-HS from Rayence Co., Ltd. on Jul 31, 2026 under K253800, a traditional 510(k). The device falls under product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager), regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 28, 2025. The decision came 245 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 Rayence Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253800?

K253800 is the FDA 510(k) for 0909FCE, 0909FCE-HS, submitted by Rayence Co., Ltd.. FDA's decision date was Jul 31, 2026, under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Who makes the 0909FCE, 0909FCE-HS?

Rayence Co., Ltd., based in Hwaseong-Si, is the applicant of record for K253800.

How long did the K253800 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Jul 31, 2026, 245 days later.

← All decisions in July 2026