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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 K121328
Device Name AGILITY
Original Applicant
ELEKTA LTD.
fleming way
linac house
crawley, west sussex,  UK rh10 9rr
Original Contact patrick hull
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/03/2012
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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