RayStation (2024A SP3)
K-Number: K252109 · 2025-12-22
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2025-12-22
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayStation (2024A SP3) is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2025-12-22 under approval number K252109. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RayStation (2024A SP3)?
RayStation (2024A SP3) is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K252109.
When was RayStation (2024A SP3) approved by the FDA?
RayStation (2024A SP3) received FDA 510(k) clearance on 2025-12-22, under approval number K252109.
What company makes RayStation (2024A SP3)?
RayStation (2024A SP3) is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation (2024A SP3)?
The FDA product code for RayStation (2024A SP3) is MUJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.