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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 K180561
Device Name MobileX Portable X-ray System
Applicant
Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
510k FDA Consulting / Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Joyce St. Germain
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/05/2018
Decision Date 04/04/2018
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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