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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 K171837
Device Name TomoTherapy Treatment Delivery System with iDMS
Applicant
Accuray Incorporated
1240 Deming Way
Madison,  WI  53717
Applicant Contact Keith Picker
Correspondent
Accuray Incorporated
1240 Deming Way
Madison,  WI  53717
Correspondent Contact Keith Picker
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/20/2017
Decision Date 07/25/2017
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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