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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name couch, radiation therapy, powered
510(k) Number K042146
Device Name ROBOCOUCH PATIENT SUPPORT SYSTEM
Applicant
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5770
Classification Product Code
JAI  
Date Received08/09/2004
Decision Date 09/17/2004
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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