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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 K122806
Device Name IMAGE WORKS PANOURA
Applicant
MIC INTERNATIONAL
4-1-17 hongo
bunkyo-ku
tokyo, 
Contact izumi maruo
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/13/2012
Decision Date 03/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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