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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K110765
Device Name FXA (TM)
Applicant
ACES GMBH
LUDWIGSTR. 26
filderstadt, bw,  DE 70794
Applicant Contact frank t trautwein
Correspondent
ACES GMBH
LUDWIGSTR. 26
filderstadt, bw,  DE 70794
Correspondent Contact frank t trautwein
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/2011
Decision Date 11/04/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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