DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM

System, X-ray, Tomography, Computed

VATECH CO., LTD.

The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Dental Computed Tomography X-ray System.

Pre-market Notification Details

Device IDK102259
510k NumberK102259
Device Name:DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant VATECH CO., LTD. 333 MEADOWLANDS PARKWAY, #303 Secaucus,  NJ  07094
ContactDave Kim
CorrespondentDave Kim
VATECH CO., LTD. 333 MEADOWLANDS PARKWAY, #303 Secaucus,  NJ  07094
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-10
Decision Date2011-02-18
Summary:summary

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