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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K203172
Device Name MOSAIQ Oncology Information System
Applicant
Elekta Solutions AB
Kungstensgatan 18, Box 7593
Stockholm,  SE SE-10393
Applicant Contact Melinda Smith
Correspondent
Elekta, Inc.
400 Perimeter Center Terrance NE, Suite 50
Atlanta,  GA  30346
Correspondent Contact Thomas Valentine
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/26/2020
Decision Date 12/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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