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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 K122119
Device Name DX-D FULL LEG FULL SPINE
Applicant
Afga Healthcare N.V.
P.O. Box 1927
Brevard,  NC  28712
Applicant Contact DAVID LEDWIG
Correspondent
Afga Healthcare N.V.
P.O. Box 1927
Brevard,  NC  28712
Correspondent Contact DAVID LEDWIG
Regulation Number892.1680
Classification Product Code
KPR  
Date Received07/17/2012
Decision Date 09/13/2012
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
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