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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K061054
Device Name AXIOM ARISTOS FX PLUS
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
E-50
Malvern,  PA  19355
Applicant Contact GARY JOHNSON
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
E-50
Malvern,  PA  19355
Correspondent Contact GARY JOHNSON
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/17/2006
Decision Date 05/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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