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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,extraoral source,digital
510(K) Number K120106
Device Name APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
Applicant
APIXIA INC.
18688 san jose ave.
industry,  CA  91748
Contact eric huang
Regulation Number872.1800
Classification Product Code
MUH  
Date Received01/13/2012
Decision Date 05/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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