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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 / October 2025 / K252911

510(k) cleared

Lux HD 2530 detector (Lux HD 2530)

Iray Imaging Technology (Haining) Limited · Oct 9, 2025 · K252911

FDA cleared the Lux HD 2530 detector (Lux HD 2530) from Iray Imaging Technology (Haining) Limited on Oct 9, 2025 under K252911, a special 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 Sep 12, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Iray Imaging Technology (Haining) Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252911?

K252911 is the FDA 510(k) for Lux HD 2530 detector (Lux HD 2530), submitted by Iray Imaging Technology (Haining) Limited. FDA's decision date was Oct 9, 2025, under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Who makes the Lux HD 2530 detector (Lux HD 2530)?

Iray Imaging Technology (Haining) Limited, based in Haining, is the applicant of record for K252911.

How long did the K252911 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Oct 9, 2025, 27 days later.

← All decisions in October 2025