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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K051133
Device Name ARCADIS AVANTIC
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY, E-50
MALVERN,  PA  19355
Applicant Contact MICHAEL J ANDREWS
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY, E-50
MALVERN,  PA  19355
Correspondent Contact MICHAEL J ANDREWS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received05/03/2005
Decision Date 06/01/2005
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
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