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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 K121934
Device Name TOMOTHERAPY TREATMENT SYSTEM
Applicant
ACCURAY INCORPORATED
1209 DEMING WAY
MADISON,  WI  53717
Applicant Contact GREG BANGE
Correspondent
ACCURAY INCORPORATED
1209 DEMING WAY
MADISON,  WI  53717
Correspondent Contact GREG BANGE
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received07/02/2012
Decision Date 08/29/2012
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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