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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 K082005
Device Name MODIFICATION TO HI-ART TREATMENT SYSTEM
Applicant
TOMOTHERAPY INCORPORATED
1209 DEMING WAY
MADISON,  WI  53717
Applicant Contact ROBERT BOVY
Correspondent
TOMOTHERAPY INCORPORATED
1209 DEMING WAY
MADISON,  WI  53717
Correspondent Contact ROBERT BOVY
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/14/2008
Decision Date 08/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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