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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 K240398
Device Name RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
Applicant
RaySearch Laboratories AB (PUBL)
Eugeniavagen 18c
Stockholm,  SE 11368
Applicant Contact Anders Wihlborg
Correspondent
RaySearch Laboratories AB (PUBL)
Eugeniavagen 18c
Stockholm,  SE 11368
Correspondent Contact Olympiada Lachana
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received02/09/2024
Decision Date 04/04/2025
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
Recalls CDRH Recalls
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