TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

System, Image Processing, Radiological

GENORAY CO., LTD.

The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Triana, Picture Archiving And Communications System.

Pre-market Notification Details

Device IDK103182
510k NumberK103182
Device Name:TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant GENORAY CO., LTD. 1073 N, BATAVIA ST Orange,  CA  92867
ContactJae Kim
CorrespondentJae Kim
GENORAY CO., LTD. 1073 N, BATAVIA ST Orange,  CA  92867
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-28
Decision Date2011-01-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809244060144 K103182 000

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