BI IMAGE-X EVOLUTION

Unit, X-ray, Extraoral With Timer

RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V.

The following data is part of a premarket notification filed by Radiotecnologia Industrial S.a. De C.v. with the FDA for Bi Image-x Evolution.

Pre-market Notification Details

Device IDK160458
510k NumberK160458
Device Name:BI IMAGE-X EVOLUTION
ClassificationUnit, X-ray, Extraoral With Timer
Applicant RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. CALLE PUEBLA SUR, MANZANA 4 LOTE 5 COLONIA JARDIN INDUSTRIAL Ixtapaluca,  MX 56535
ContactMarcelo Mojica
CorrespondentClaude Berthoin
DENTERPRISE INTERNATIONAL, INC./ 510K FDA CONSULTING 100 EAST GRANADA BLVD SUITE 219 Ormond Beach,  FL  32176
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-19
Decision Date2016-06-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D881RXEPWEXP0 K160458 000
D881RXEMWEXP0 K160458 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.