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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 K220141
Device Name RayStation 11B
Applicant
RaySearch Laboratories AB (PUBL)
Eugeniavägen 18
Stockholm,  SE 113 68
Applicant Contact David Hedfors
Correspondent
RaySearch Laboratories AB (PUBL)
Eugeniavägen 18
Stockholm,  SE 113 68
Correspondent Contact David Hedfors
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/18/2022
Decision Date 04/15/2022
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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