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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K160458
Device Name BI IMAGE-X EVOLUTION
Applicant
Radiotecnologia Industrial S.A. DE C.V.
Calle Puebla Sur, Manzana 4 Lote 5 Colonia Jardin Industrial
Ixtapaluca,  MX 56535
Applicant Contact Marcelo Mojica
Correspondent
Denterprise International, Inc. / 510k FDA Consulting
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/19/2016
Decision Date 06/20/2016
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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