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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 K123808
Device Name AGILITY
Applicant
Elekta , Ltd.
Fleming Way
Linac House
Crawley, West Sussex,  GB RH10 9RR
Applicant Contact Patrick Hull
Correspondent
Elekta , Ltd.
Fleming Way
Linac House
Crawley, West Sussex,  GB RH10 9RR
Correspondent Contact Patrick Hull
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/11/2012
Decision Date 04/04/2013
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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