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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
Applicant
ELEKTA INC. D/B/A NUCLETRON CORPORATION
7 ST. PAUL ST, STE 1660
BALTIMORE,  MD  21202
Applicant Contact THOMAS VALENTINE
Correspondent
ELEKTA INC. D/B/A NUCLETRON CORPORATION
7 ST. PAUL ST, STE 1660
BALTIMORE,  MD  21202
Correspondent Contact THOMAS VALENTINE
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/15/2012
Decision Date 07/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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