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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 K161144
Device Name iDMS Data Management System
Applicant
Accuray Incorporated
1310 Chesapeake Ter.
Sunnyvale,  CA  94089
Applicant Contact Elizabeth Osuna
Correspondent
Accuray Incorporated
1310 Chesapeake Ter.
Sunnyvale,  CA  94089
Correspondent Contact Elizabeth Osuna
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/22/2016
Decision Date 06/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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