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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 K200487
Device Name RayCare 3.1
Applicant
RaySearch Laboratories AB (publ)
Sveavägen 44
Stockholm,  SE 11134
Applicant Contact Viktoria Hammarstedt
Correspondent
RaySearch Laboratories AB (publ)
Sveavägen 44
Stockholm,  SE 11134
Correspondent Contact Viktoria Hammarstedt
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received02/27/2020
Decision Date 06/10/2020
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
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