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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, stationary
510(k) Number K013826
Device Name AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
Original Applicant
SIEMENS MEDICAL SYSTEMS, INC.
186 wood avenue south
iselin,  NJ  08830
Original Contact sandra robinson
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/19/2001
Decision Date 02/01/2002
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
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