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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K252109
Device Name RayStation (2024A SP3)
Applicant
RaySearch Laboratories AB (PUBL)
Eugeniavägen 18c
Stockholm,  SE 11368
Applicant Contact Olympiada Lachana
Correspondent
RaySearch Laboratories AB (PUBL)
Eugeniavägen 18c
Stockholm,  SE 11368
Correspondent Contact Olympiada Lachana
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/07/2025
Decision Date 12/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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