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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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