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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 K222312
Device Name RayStation 12A
Applicant
RaySearch Laboratories AB (publ)
Eugeniavagen 18
Stockholm,  SE 113 68
Applicant Contact David Hedfors
Correspondent
RaySearch Laboratories AB (publ)
Eugeniavagen 18
Stockholm,  SE 113 68
Correspondent Contact David Hedfors
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/01/2022
Decision Date 03/29/2023
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
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