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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 K103606
Device Name ARTISTE SOLUTION WITH SYS_VB50 UPDATE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Applicant Contact CHRISTINE DUNBAR
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Correspondent Contact CHRISTINE DUNBAR
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/09/2010
Decision Date 04/15/2011
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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