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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
Recalls CDRH Recalls
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