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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 K031764
Device Name ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Applicant Contact KEN NEHMER
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Correspondent Contact KEN NEHMER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/09/2003
Decision Date 09/05/2003
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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