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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 K121663
Device Name CLARITY
Applicant
ELEKTA LTD.
2050 BLEURY, SUITE 200
MONTREAL,  CA H3A 2J5
Applicant Contact GEORGE PAPAGIANNIS
Correspondent
ELEKTA LTD.
2050 BLEURY, SUITE 200
MONTREAL,  CA H3A 2J5
Correspondent Contact GEORGE PAPAGIANNIS
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IWB   KPQ  
Date Received06/05/2012
Decision Date 12/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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