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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K060912
Device Name MODIFICATION TO: HI-ART SYSTEM
Applicant
TOMOTHERAPY INCORPORATED
1240 DEMING WAY
MADISON,  WI  53717
Applicant Contact KENNETH D BUROKER
Correspondent
TOMOTHERAPY INCORPORATED
1240 DEMING WAY
MADISON,  WI  53717
Correspondent Contact KENNETH D BUROKER
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received04/03/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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