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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 K062623
Device Name AXIOM LUMINOS DRF
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern,  PA  19355 1406
Original Contact gary johnson
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received09/05/2006
Decision Date 08/22/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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