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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 K200569
Device Name RayStation
RaySearch Laboratories AB (publ)
Sveavägen 44
Stockholm,  SE 11134
Applicant Contact Viktoria Hammarstedt
RaySearch Laboratories AB (publ)
Sveavägen 44
Stockholm,  SE 11134
Correspondent Contact Viktoria Hammarstedt
Regulation Number892.5050
Classification Product Code
Date Received03/04/2020
Decision Date 09/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls