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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
Applicant Contact ERIC HUANG
Correspondent
APIXIA INC.
18688 SAN JOSE AVE.
INDUSTRY,  CA  91748
Correspondent Contact ERIC HUANG
Regulation Number872.1800
Classification Product Code
MUH  
Date Received01/13/2012
Decision Date 05/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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