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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K052202
Device Name AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY, E-50
MALVERN,  PA  19355
Applicant Contact GARY JOHNSON
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY, E-50
MALVERN,  PA  19355
Correspondent Contact GARY JOHNSON
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received08/12/2005
Decision Date 03/07/2006
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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