DENTAL IMAGING SOFTWARE

System, Image Processing, Radiological

TROPHY

The following data is part of a premarket notification filed by Trophy with the FDA for Dental Imaging Software.

Pre-market Notification Details

Device IDK141607
510k NumberK141607
Device Name:DENTAL IMAGING SOFTWARE
ClassificationSystem, Image Processing, Radiological
Applicant TROPHY 4 RUE F. PELLOUTIER CROISSY - BEAUBOURG Marne La Vallee Cedex 2,  FR 77435
ContactMarie-pierre Labat-camy
CorrespondentMarie-pierre Labat-camy
TROPHY 4 RUE F. PELLOUTIER CROISSY - BEAUBOURG Marne La Vallee Cedex 2,  FR 77435
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-16
Decision Date2014-09-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60192155319570 K141607 000
60192155314308 K141607 000

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