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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
Recalls CDRH Recalls
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