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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 K150873
Device Name CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
Applicant
Accuray Incorporated
1310 Chesapeake Terrace
Sunnyvale,  CA  94089
Applicant Contact Shweta Kaushik
Correspondent
Accuray Incorporated
1310 Chesapeake Terrace
Sunnyvale,  CA  94089
Correspondent Contact Shweta Kaushik
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/01/2015
Decision Date 07/01/2015
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
Recalls CDRH Recalls
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