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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 K120233
Device Name SYNCHRONY RESPIRATORY TRACKING SYSTEM
Applicant
Accuray Incorporated
1310 Chesapeake Ter.
Sunnyvale,  CA  94089
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
Accuray Incorporated
1310 Chesapeake Ter.
Sunnyvale,  CA  94089
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/25/2012
Decision Date 03/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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