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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)
Applicant
Siemens Medical Systems, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact SANDRA ROBINSON
Correspondent
Siemens Medical Systems, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact SANDRA ROBINSON
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/19/2001
Decision Date 02/01/2002
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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