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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 / December 2025 / K252109

510(k) cleared

RayStation (2024A SP3)

RaySearch Laboratories AB (PUBL) · Dec 22, 2025 · K252109

FDA cleared the RayStation (2024A SP3) from RaySearch Laboratories AB (PUBL) on Dec 22, 2025 under K252109, a traditional 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 7, 2025. The decision came 168 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 RaySearch Laboratories AB (PUBL) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252109?

K252109 is the FDA 510(k) for RayStation (2024A SP3), submitted by RaySearch Laboratories AB (PUBL). FDA's decision date was Dec 22, 2025, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the RayStation (2024A SP3)?

RaySearch Laboratories AB (PUBL), based in Stockholm, is the applicant of record for K252109.

How long did the K252109 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Dec 22, 2025, 168 days later.

← All decisions in December 2025