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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K130443
Model 9306X51191
Device Name I-MAX TOUCH 3D
Original Applicant
110 e. granada blvd.
suite 207
ormond beach,  FL  32176
Original Contact claude berthoin
Regulation Number892.1750
Classification Product Code
Date Received02/27/2013
Decision Date 06/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No