Cleared Traditional

RayStation (2024A SP3)

K252109 · RaySearch Laboratories AB (PUBL) · Radiology
Dec 2025
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K252109 is an FDA 510(k) clearance for the RayStation (2024A SP3), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by RaySearch Laboratories AB (PUBL) (Stockholm, SE). The FDA issued a Cleared decision on December 22, 2025, 168 days after receiving the submission on July 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252109 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2025
Decision Date December 22, 2025
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050