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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 K072485
Device Name ARTISTE MV SA
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16787 BERNARDO CENTER DRIVE
SAN DIEGO,  CA  92128
Applicant Contact ERIK RODRIGUEZ
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16787 BERNARDO CENTER DRIVE
SAN DIEGO,  CA  92128
Correspondent Contact ERIK RODRIGUEZ
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/04/2007
Decision Date 12/27/2007
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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