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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 K112776
Device Name TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
Applicant
TOMOTHERAPY INCORPORATED
1240 DEMING WAY
MADISON,  WI  53717 -1954
Applicant Contact GREG BANGE
Correspondent
TOMOTHERAPY INCORPORATED
1240 DEMING WAY
MADISON,  WI  53717 -1954
Correspondent Contact GREG BANGE
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/26/2011
Decision Date 12/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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