RADIOLOGICAL IMAGE PROCESSING SYSTEM

System, Image Processing, Radiological

VATECH CO., LTD.

The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Radiological Image Processing System.

Pre-market Notification Details

Device IDK102078
510k NumberK102078
Device Name:RADIOLOGICAL IMAGE PROCESSING SYSTEM
ClassificationSystem, Image Processing, Radiological
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 CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-26
Decision Date2011-08-10
Summary:summary

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