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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 K112446
Device Name TOMOTHERAPY TREATMENT SYSTEM
Applicant
TOMOTHERAPY INCORPORATED
1209 DEMING WAY
MADISON,  WI  53717
Applicant Contact GREG BANGE
Correspondent
TOMOTHERAPY INCORPORATED
1209 DEMING WAY
MADISON,  WI  53717
Correspondent Contact GREG BANGE
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/24/2011
Decision Date 10/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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