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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,planning,radiation therapy treatment
510(k) Number K121448
Device Name ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
Original Applicant
ELEKTA INC. D/B/A NUCLETRON CORPORATION
7 st. paul st, ste 1660
baltimore,  MD  21202
Original Contact thomas valentine
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/15/2012
Decision Date 07/02/2012
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
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