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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 K191384
Device Name RayCare 2.3
RaySearch Laboratories AB (publ)
Sveavagen 44
Stockholm,  SE 11134
Applicant Contact David Hedfors
RaySearch Laboratories AB (publ)
Sveavagen 44
Stockholm,  SE 11134
Correspondent Contact David Hedfors
Regulation Number892.5050
Classification Product Code
Date Received05/23/2019
Decision Date 07/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No