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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 K162619
Device Name I View and Imagen Sensor
Applicant
Trident S.R.L
Via Verdi 20
Assago,  IT 20090
Applicant Contact GIORGIO RIZZO
Correspondent
Denterprise International, Inc. / 510k FDA Consulting
100 E. Granada Blvd.
Suite 219
Ormond Beach,  FL  32174
Correspondent Contact CLAUDE BERTHOIN
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/20/2016
Decision Date 11/04/2016
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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