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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 K210645
Device Name RayStation 10.1
Applicant
RaySearch Laboratories AB (publ)
Sveavagen 44
Stockholm,  SE 111 34
Applicant Contact David Hedfors
Correspondent
RaySearch Laboratories AB (publ)
Sveavagen 44
Stockholm,  SE 111 34
Correspondent Contact David Hedfors
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/03/2021
Decision Date 06/29/2021
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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