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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,  JP 113-0033
Applicant Contact IZUMI MARUO
Correspondent
Mic International
4-1-17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Correspondent Contact IZUMI MARUO
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/13/2012
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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