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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 K141855
Device Name CLARITY
Applicant
Elekta , Ltd.
2050 Bleury, Suite 200
Montreal, Quebec,  CA H3A 2J5
Correspondent
Elekta , Ltd.
2050 Bleury, Suite 200
Montreal, Quebec,  CA H3A 2J5
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IWB   KPQ  
Date Received07/09/2014
Decision Date 10/08/2014
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
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