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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 K212114
Device Name Elekta Unity
Applicant
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm,  SE SE10393
Applicant Contact Melinda Smith
Correspondent
Elekta, Inc.
400 Perimeter Center Ter. NE
Suite 50
Atlanta,  GA  30346
Correspondent Contact Melinda Smith
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received07/07/2021
Decision Date 10/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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