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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 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 Number892.1680
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
Recalls CDRH Recalls
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