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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K141607
Device Name DENTAL IMAGING SOFTWARE
Applicant
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4 Rue F. Pelloutier
Croissy - Beaubourg
Marne La Vallee Cedex 2,  FR 77435
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
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4 Rue F. Pelloutier
Croissy - Beaubourg
Marne La Vallee Cedex 2,  FR 77435
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/16/2014
Decision Date 09/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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